The global prevalence of irritable bowel syndrome (IBS) could be lower based on how stringent a criteria researchers use.

A team, led by Priya Oka, MBBS, Leeds Gastroenterology Institute, St James's University Hospital, determined the true global prevalence of irritable bowel syndrome.

While IBS represents one of the most common functional bowel disorders, community prevalence can vary widely between different countries. This variation might be explained by previous cross-sectional surveys that neither applied uniform diagnostic criteria or used identical methodology, rather than being due to true global variability.

In the systematic review and meta-analysis, the investigators identified data from all population-based studies using relatively uniform methodology. These studies used only the most recent iterations of the Rome criteria—Rome III and Rome IV.

The team searched several databases to identify cross-sectional surveys reporting the prevalence of irritable bowel syndrome in adults, according to the Rome III or Rome IV criteria.

The researchers also performed a manual search of a selection of conference proceedings for relevant abstracts published between 2006-2019.

They then extracted the prevalence data for all found studies, according to the criteria used to define the presence of IBS. In the meta-analysis, the investigators estimated pooled prevalence rates, according to study location and certain other characteristics such as sex and IBS subtype.

Overall, they identified 4143 citations, of which 57 studies were deemed eligible involving 92 separate adult populations totaling 423,362 participants. The pooled disease prevalence of IBS in the 53 studies from 38 countries involving 395,385 participants using the Rome III criteria was 9.2% (95% CI, 7.6-10.8; 

On the other hand, the pooled IBS prevalence from 6 studies in 34 countries involving 82,476 individuals using the Rome IV criteria was 3.8% (95% CI, 3.1-4.5; 

The investigators discovered that IBS mixed bowel habit was the most common subtype in the Rome III criteria studies. This was reported by 33.8% (95% CI, 27.8-40.0; 2=98.1%) of patients fulfilling criteria for IBS (ie, 3.7% [2·6–4·9] of all included participants had IBS-M).

However, IBS with diarrhea was the most common subtype with the Rome IV criteria (reported by 31.5% [95% CI, 23.2–40.5; 

 2= 98.1% 61.6%] of people with IBS, corresponding to 1.4% [0.9–1.9] of all included participants having IBS-D).

The investigators also found higher rates of IBS in women than males (12.0% [95% CI, 9.3–15.0] 

 8.6% [6.3–11.2]; OR, 1.46 [95% CI, 1.33–1.59]).

Prevalence also varied significantly between individual countries. This variability persisted even when the same diagnostic criteria was applied and identical methodology was using in studies.

“Even when uniform symptom-based criteria are applied, based on identical methodology, to define the presence of IBS, prevalence varies substantially between countries,” the authors wrote. “Prevalence was substantially lower with the Rome IV criteria, suggesting that these more restrictive criteria might be less suitable than Rome III for population-based epidemiological surveys.”

Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis,

Articles

There is a higher prevalence of IBS found in women than men.

Irritable Bowel Syndrome Rates Might Be Lower Than Previously Thought

 reaching the US, emergent medicines and equipment were quickly lacking. As much stress was put on social distancing parameters and protocol to expedite promising agents against the virus, there was an even greater call for often relied-upon resources.

Take, for example, blood. By March 17, the American Red Cross announced a severe blood shortage due to mass cancellation of donor drives. The situation highlighted a significant issue now unique to the COVID-19 pandemic: the virus affected non-patients as severely as it does infected persons.

Blood transfusions, a routinely critical facet of 

 care, were at risk of lacking their most precious commodity.

One way to combat the matter was emphasizing use of therapies that reduced the need for transfusions. Newest sickle cell disease therapy voxelotor (Oxbryta) fit that bill.

In the next segment of an interview with 

, Richard Drachtman, MD, clinical section chief of Pediatric Hematology/Oncology at Rutgers Medicine, discussed how the recently-approved agent came into benefit for prescribing early into the pandemic.

It’s already often the mindset of a hematologist to over-value donor blood. Once COVID-19 began to limit its availability further—especially in hard-hit areas including Drachtman’s New Brunswick, NJ—it became a responsibility to reduce the need for patient transfusions.

“Use of voxelotor has allowed me to do that,” Drachtman said. “In this time, it’s like ‘The Omega Man’ practicing medicine, driving to work in an empty town. It really has helped quite a bit.”

In Drachtman’s practice, patient volume has recently begun to increase. But transfusion need has remained low due to agents including voxelotor.

“It gives you one more option of being able to avoid transfusions in this one population of patients,” he said.

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The pandemic has burdened blood drives nationally. A new sickle cell drug keeps patients from needing as many transfusions.

How Voxelotor Benefits the Blood Shortage

The ability to communicate with family members and other loved ones can be extremely difficult for patients suffering from a 

While in-person training for both the patient and communication partner has shown benefits in the past, with the advent of new technology, telehealth might be another option.

A team, led by Rachael Rietdijk, BAppSc, Faculty of Health Sciences, The University of Sydney,investigated the efficacy of telehealth-based and in-person social communication skills training for individuals with moderate-to-severe traumatic brain injuries based on outcomes reported by the survivor and a close communication partner.

The standard program often involves 35 hours of intervention consisting of a combination of group sessions and dyad sessions that are attended by both the injured patient and their communication partner. However, telehealth could allow a more expansive therapy service be reducing some of the time constraints linked to in-person training.

The partially randomized controlled trial contained a telehealth intervention group using a program called TBIconneCT, an in-person intervention group that uses the TBI Express therapy program, and a historical control arm.

The investigators examined 51 adults at least 6 months following a moderate or severe traumatic brain injury. Each patient had exhibited some communication skills deficits. The investigators also utilized communication partners, including family members, friends, and paid care of the injured individual.

The investigators sought main measures of La Trobe Communication Questionnaire total score, as well as the number of items with perceived positive change.

The researchers found trained participants had significantly more items with perceived positive change than the historical controls did. There was also a medium effect size in the sample observed for improvements in total score reported by trained communication partners following treatment.

Comparisons between telehealth and in-person groups showed medium to large effect sizes in the sample. This favored the telehealth group on certain La Trobe Communication Questionnaire variables.

“Whether delivered via telehealth or in-person, social communication skills training led to perceived positive change in communication skills,” the authors wrote. “It was unexpected that outcomes for the telehealth group were better than for the in-person group on some variables.”

Providing communication partners with skills can help enable those suffering from traumatic brain injuries to have effective conversations and create a more positive daily communication environment.

This training involves focusing on addressing negative patterns that communication partners may use in conversations with patients with TBI, including failing to follow up on the person's contributions, not giving enough information to support the person's comprehension, using questions designed to test the person's memory rather than asking for meaningful information, and querying the person's accuracy.

Training can facilitate collaborative interactions between the person with TBI and communication partners.

A Clinical Trial Investigating Telehealth and In-Person Social Communication Skills Training for People With Traumatic Brain Injury: Participant-Reported Communication Outcomes

The Journal of Head Trauma Rehabilitation

A telehealth group showed better outcomes than an in-person training group for some variables of communication skills for individuals who suffered a traumatic brain injury.

Telehealth Helps Traumatic Brain Injury Patients Recover Communication Skills

The indication is the fifth for ustekinumab (STELARA)

The approval was based on 12-week outcomes in skin clearance

Ustekinumab is dosed 4 times annually after 2 starter doses

The US Food and Drug Administration (FDA) has approved an expanded indication for ustekinumab (STELARA) as a treatment for pediatric patients aged 6-11 years old who have skin lesions or plaques associated with 

The injection interleukin-12 and -23 (IL-12; IL-23) inhibitor becomes the first biologic approved to target such pathways in this patient age population. It was approved based on the results of the CADMUS Junior study, an open-label, single-arm, multicenter phase 3 clinical in which 44 patients with moderate to severe plaque psoriasis were assessed.

Investigators observed that 77% of treated patients achieved clear or almost clear skin at week 12, following their second dose of ustekinumab. In secondary endpoints, 84% and 64% of treated patients achieved Psoriasis Area and Severity Index (PASI) scores of 75 and 90, respectively, at week 12.

The observed ustekinumab safety profile was similar to that observed in adults with plaque psoriasis.

As an injection therapy dosed 4 times annually after 2 starter doses, ustekinumab has been previously approved by the FDA for the treatment of adults and pediatric patients with moderate to severe plaque psoriasis who are phototherapy of systemic therapy candidates; adultsvwith active psoriatic arthritis; adults with Crohn’s disease; and adults with moderalty to severe active ulcerative colitis.

As plaque psoriasis presents variably in patients, clinicians face a challenge in both diagnosing and treating the chronic condition, Stacie Bell, PhD, Chief Scientific and Medical Officer of the National Psoriasis Foundation, said.

“Especially in the pediatric population, it is important for patients, parents and physicians to work together to identify an appropriate treatment,” Bell said in a 

 “The approval of new treatment options is an exciting step forward to address the unmet needs of children living with psoriasis.”

The expansion makes history for the injection biologic.

FDA Expands Ustekinumab to Pediatric Plaque Psoriasis

There are high costs related to US Food and Drug Administration (FDA)-approved anti-VEGF agents for 

neovascular age-related macular degeneration

 (nAMD). However, step-therapy requiring initial treatment with bevacizumab is currently being proposed nationally.

This proposal is not without controversy, as some do not believe in the efficacy of bevacizumab step-therapy.

A team, led by Jonathan Siktberg, BBA, examined the efficacy of bevacizumab step-therapy to treat neovascular age-related macular degeneration. The findings of the research presented were at the 

American Society of Retina Specialists (ASRS 2020) Virtual Sessions

The researchers performed a retrospective cohort study of the step-therapy protocol at the Vanderbilt University School of Medicine, which was instituted in 2012. The investigators analyzed the clinical course of 133 patients meeting the inclusion criteria of being treated within the nAMD step-therapy protocol with at least 3 consecutive monthly injections of bevacizumab from January 2012 to August 2018.

The team excluded patients if they had past intraocular surgery other than cataract surgery. The age range was 59-106.

The investigators sought primary outcomes of the success rate of the step-therapy, defined as achieving a stable injection regimen without the recurrence of neovascular age-related macular degeneration, the loss of 3 or more Snellen chart lines, or requirement of switching to an FDA-approved anti-VEGF agent.

Of the 133 patients in the study, 106 (80%) achieved treatment stability on the study drug and 70 (53%) were stable on injections every 8 weeks or longer. In addition, 36 patients (27%) required injections more frequently than every 8 weeks. For the 27 patients who failed, 14 did not switch to another drug and 13 were switched to aflibercept.

“We conclude that treatment of neovascular AMD with a regimen consisting of bevacizumab as first-line therapy is efficacious with only a minority of patients meeting failure criteria,” the authors wrote. “Given the cost-savings associated with bevacizumab compared to FDA-approved alternatives, providers should consider bevacizumab as first-line for the treatment of neovascular AMD.”

Findings of a recent study demonstrate dexamethasone implant and anti-vascular endothelial growth factor (VEGF) treatment may be useful in 

Raja Narayanan, MD, MBA, and a team of investigators evaluated the efficacy of combination dexamethasone implant and anti-VEGF therapy in eyes resistant to anti-VEGF monotherapy in age-related macular degeneration in an Asian population. A retrospective study was conducted among 16 patients (17 eyes) who were resistant to anti-VEGF injections. Cases were resistant if they had less than 10% reduction in macular thickness on optical coherence tomography.

Narayanan reported a significant reduction in macular edema as seen on optical coherence tomography. The mean thickness reduced from 612.05 microns to 306.81 microns at the last visit, which was statistically significant (

The visual acuity was not statistically significant from baseline at 1 month and last follow-up. The mean injection-free interval in patients after the dexamethasone implant was 169.8 days, which was significantly greater than the pre-injection mean of 35.2 days (

Efficacy of Bevacizumab Step-Therapy for Age-Related Macular Degeneration

There has been controversy over the efficacy and safety of step-therapy for neovascular age-related macular degeneration. 

Bevacizumab Step-Therapy Efficacious on nAMD Trial

Investigators have challenged the belief that 

 is a common cause of mortality, based on their new findings from a systematic review and meta-analysis of trials which observed the causal effect of VTE reduction on patient mortality.

In new findings from an analysis of large-scale, randomized, controlled trials, a team of US-based investigators reported an insignificant evidence of VTE effect on overall mortality.

The team, led by Nicholas D. Klemen, MD, of the Memorial Sloan Kettering Cancer Center, also challenged the utility of composite endpoints in VTE prevention assessments based on their findings.

Their systematic review and meta-analysis included research into randomized, controlled trials published in 1 of 4 databases from January 1993- March 2018. Eligible studies included patients who were at elevated VTE risk, and were assigned randomly to either anticoagulant or antiplatelet therapy versus placebo or no therapy.

Trials including an active control agent were excluded, as they may mitigate the understood lethality of VTE. Investigators also excluded trials for which mortality data were unavailable.

Meta-analysis heterogeneity was modeled via Bayesian framework. Overall mortality served as the primary endpoint; pulmonary embolism, fatal pulmonary embolism, and major patient bleeding were secondary endpoints.

“We focused our analyses on studies reporting statistically significant effects of prevention on venous thromboembolism endpoints,” Klemen and colleagues wrote.

Of the screened 4229 studies, 86 were identified as eligible randomized, controlled trials. From those, 52 were positive—and showed through data from 70,000-plus patients a significantly increased risk of VTE in control patients versus treatment arms (RR, 2.74; 95 CI%, 2.32-3.31; 

Through the meta-analysis, Klemen and colleagues observed a non-impactful causal effect of VTE prevention mortality: control group mortality included 3391 (9.8%) patients, while treatment arm mortality included 3498 (9.8%) (RR, 1.01; 95% CI, 0.97-1.06; 

 = .58). Investigators additionally observed low heterogeneity.

Regarding secondary endpoints, control patients were actually less likely to report major bleeding than treated patients (RR, 0.60; 95% CI, 0.47-0.75; 

However, investigators did observe a greater rate of overall pulmonary embolism (RR, 2.22; 95% CI 1.78-2.89; 

 <.0001) and fatal pulmonary embolism (RR, 1.58; 95% CI, 1.14-2.19; 

 = .01) in control patients versus treatment arms.

The team’s meta-analysis of the additional 34 negative trials showed similar results across all endpoints, though fatal pulmonary embolism’s effect on control versus treated patients was observed to be weaker.

The new findings come at a time when major organizations including the American Heart Association (AHA) and International Society on Thrombosis and Hemostasis (ISTH) just recently called for the advancement of preventive VTE research—noting a 2008 Surgeon General’s Call to Action for improved VTE care that went largely unanswered more than a decade ago.

 regarding the AHA and ISTH statement, Maja Zaric, MD, interventional cardiologist and assistant professor at Zucker Medical School, discussed the complicated network of morbidities associated with VTE—including pulmonary embolisms and bleeding risks.

In some instances, more than 50% of patients are at risk of such additional burdens.

“I don’t think we’ve moved an iota since 2008 in terms of dropping those numbers down to a measurable level,” Zaric said. “The research has been done…we can’t say there hasn’t been any effort to do so.”

Given the new findings from Klemen and colleagues, there may be reason to look more closely into these conflicting comorbidities than VTE itself.

“The perception that venous thromboembolism is a common cause of mortality should be revised considering the null effect of venous thromboembolism prevention on mortality,” they concluded. “Our findings call into question the use of composite endpoints in venous thromboembolism-prevention trials and provide rationale for de-escalation trials.”

Mortality risk associated with venous thromboembolism: a systematic review and Bayesian meta-analysis

A new systematic review and meta-analysis challenges the notion that preventing VTE is associated reduced mortality risk.

VTE May Not Be Significant Driver of Death

Every facet of care and every regular gathering of medical fellows has been thrown off its axis by the ongoing coronavirus 2019 (COVID-19) pandemic.

Telemedicine has entered the fold in areas where in-person healthcare can be avoided, and clinicians have become investigators to their own daily practices.

The pandemic’s effect on 

 is no less interesting than any other specialty, as clinicians are faced with an older patient clientele.

“We’ll see how that plays out in the coming months and years, but I suspect through this crisis, I think it’ll be pretty much be business as usual with taking care of patients,” W. Lloyd Clark, MD, told 

.

In the final segment of an interview with 

American Society of Retina Specialists (ASRS) 2020 Virtual Meeting

 this weekend, Clark, of the Palmetto Retinal Center, discussed how the implementation of retina-based care technology has been slow the last few months, with the hoped-for platforms just not yet being available.

Nonetheless, Clark praised the role of technology in meetings like ASRS 2020 itself, noting the “social, collegial, cohesive” nature of the retina clinicians who regularly attend the meeting and looked forward to the weekend of online connection.

“Some of the smaller meetings have been very creative, entertaining, a lot of fun to participate in,” Clark said. “There’s been some appetite to get online and see our colleagues. Because we are, as a specialty, used to meeting a lot, and used to seeing our colleagues. There’s been a desire to reconnect.”

A perspective on what's moved virtually, and what hasn't, since the pandemic began in March.

How Ophthalmology Has Evolved During COVID-19

US Food and Drug Administration (FDA) granted approval to voxelotor (Oxbryta)

, a deoxygenated sickle hemoglovin polymerization inhibitor, for the treatment of 

The therapy was touted for its ability to reduce sickle cell binding, showing a 51.1% hemoglobin response rate among patients administered 1500 mg dose in the pivotal trial included in the FDA submission.

So, nearing 1 year as an available therapy in an at-need field, where does voxelotor stand now?

, Richard Drachtman, MD, professor of Pediatrics and Clinical Section Chief of Pediatric Hematology/Oncology at Rutgers Medical, discussed his own excitement surrounding the original voxelotor approval—and his own experiences in prescribing and caring for patients with sickle cell.

“It’s been a very interesting time,” Drachtman told 

. “We’ve been prescribing it since late December-early January, and we’re seeing some very good results.”

Drachtman explained he had his own “short list” of patients he anticipated would benefit most from the new therapy once it was marketed: those with the lowest hemoglobin counts and hemolytic characteristics.

Included among those patients were the 10% to 20% of all sickle cell disease patients with primary hemolysis—who are often subjected to burdensome blood transfusions.

Drachtman also set parameters for discussing voxelotor with potentially eligible patients based on hemoglobin levels. It’s now that he’s beginning to see the impact of the new therapy which he prescribed to patients 2-3 months ago.

“We’re seeing in the patients who had very low hemoglobin levels and were very hemolytic to start significant rises in hemoglobin and significant drops in bilirubin,” he explained. “We’re seeing them not needing transfusions anymore, or to the same degree. We’re seeing significant changes in the use of healthcare, as a result.”

How has the new agent fared in its indicated patients in its first year on the market?

Voxelotor in Sickle Cell Disease

Upadacitinib (RINVOQ) plus topical corticosteroids may be an effective treatment for 

.

The news comes following the results of AD Up, the third pivotal phase 3 study of the drug, which met the co-primary and all secondary endpoints. Namely, those who used upadacitinib plus topical corticosteroids achieved at least a 75% improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.

A team of investigators from AbbVie found significantly more patients who received either a 15 mg or 30 mg dose of upadacitinib plus topical corticosteroids demonstrated improvement in skin clearance compared to placebo plus topical corticosteroids at week 16. Of those who received 15 mg or 30 mg of upadacitinib plus the topical corticosteroids 65% and 77%, respectively, achieved EASI 75, while only 26% of patients who received placebo plus topical corticosteroid achieved such a feat (

 <.001).

Among patients treated with upadacitinib 15 mg or 30 mg plus topical corticosteroids, 40% and 59%, respectively, achieved vIGA-AD 0/1, compared to 11% of patients receiving placebo plus topical corticosteroids (

 <.001).

“Many of the current treatment options rely on patients to self-manage their condition, often with multiple applications of topicals,” Kristian Reich, MD, principal investigator, said in 

. “Patients could benefit from more therapeutic options that can help control symptoms without the constant need for concomitant topicals, as they strive for relief from this life-long, chronic disease.”

Further findings of AD Up emphasize patients treated with upadacitinib plus topical corticosteroids experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale of at least 4, compared to patients treated with placebo plus topical corticosteroids. In fact, at week 16, 52% of patients in the 15 mg upadacitinib group, and 64% of those in the 30 mg group plus topical corticosteroids achieved the endpoint compared to 15% of patients who received placebo plus topical corticosteroids (

 <.001).

In an additional analysis, treated with either dose of upadacitinib resulted in a higher mean number of topical corticosteroid-free days up to week 16 versus placebo. A topical corticosteroid-free day was defined by a response of EASI 75 or greater without the use of a topical corticosteroid. Those treated with upadacitinib 15 mg or 30 mg had a mean of 34 and 47 topical corticosteroid-free days while maintaining EASI 75 compared with a mean of 8 days for the placebo group (nominal 

 <.001).

There were no new safety risks observed during the 16-week placebo-controlled period. Only 2.3% of patients in the 15 mg group and 1.3% of the 30 mg groups experienced serious adverse events compared to 3% of those in the placebo group. The most common adverse events for the upadacitinib patients were nasopharyngitis, acne, and upper respiratory tract infection.

“These data build on the positive results from our previous studies in atopic dermatitis, now with additional perspective on the efficacy of (upadacitinib) used with a mainstay treatment for people living with the disease—topical steroids,” Tom Hudson, MD, senior vice president of R&D and chief scientific officer of AbbVie, said.

The data from the phase 3 AD Up trial add to existing knowledge of the efficacy and safety of upadacitinib for patients with atopic dermatitis.

Upadacitinib Plus Topical Corticosteroids Effective for Atopic Dermatitis

Early phase results show a combination of OPT-302 and aflibercept could be beneficial to patients suffering from 

American Society of Retina Specialists 2020 (ASRS 2020) Virtual Sessions

, a team, led by David S. Boyer, MD, evaluated the safety, visual function, and anatomic outcomes of switching patients with persistent diabetic macular edema from anti-VEGF-A monotherapy to combination therapy of OPT-302 with aflibercept.

OPT-302 inhibits VEGF-C/-D and could contribute to treatment resistance with VEGF-A suppression.

In the phase 1B study, the investigators examined patients receiving escalating doses of OPT-302 (0.3, 1 or 2 mg) with aflibercept (2mg) in 3 separate cohorts. Next, in a phase 2a study, the investigators will examine about 108 patients randomized to either aflibercept with OPT-302 (2mg) or aflibercept alone.

Each patient received intravitreal injections of aflibercept with OPT-302 once every 4 weeks over the course of 12 weeks. They were then followed an additional 12 weeks, where aflibercept retreatment was available as needed if there was at least a 5 letter decline in best-corrected visual acuity (BCVA) or at least a 10% increase in retinal thickness.

The investigators sought several outcomes, including safety, the effects on BCVA, and anatomical changes.

In the interim analysis from the preceding phase 1b dose escalation study, the investigators examined 9 patients with a mean injections of prior anti-VEGF-A monotherapy of 6.3. The last one was given a mean 36 days prior to switching to combination therapy.

They found that multiple dosing of IVT aflibercept with OPT-302 was well tolerated at all 3 dosing levels with no dose limiting toxicities.

For the whole group analysis, the mean change in BCVA at week 12 increased by 7.7 letters (95% CI, 2-13.3) from baseline (65 letters). A dose response relationship of improved BCVA was also observed with increasing doses OPT-302 combined with aflibercept.

The group also found a reduction in central subfield thickness at week 12 of -71µm (95% CI, -117 to -26) from baseline (434 µm) and 6 of 9 (67%) patients had at least a 50% reduction in excess foveal thickness as measured on SD-OCT.

“Conversion to combination OPT-302 with aflibercept was well tolerated with improved visual and anatomic outcomes in patients with persistent DME despite prior anti-VEGF-A monotherapy,” the authors wrote. “Thus, dual-targeted inhibition of VEGF-C/-D and VEGF-A may hold promise in the management of DME.”

In another study presented at ASRS 2020, investigators suggest new methods to improving long-term visual outcomes in 

 with diabetic macular edema are needed.

The team assessed routine clinical care practices for participants. They retrospectively collected data on clinical visits and retina treatments in the study eye occurring between the two- and five-year extension period.

The primary objective for the 3 years after Protocol T was stopped was to provide information on treatment course, visual acuity, and diabetic macular edema. The main objective did not include comparing treatment groups after 2 years, Pieramici said during the presentation of his research team’s data and findings.

The study, “

Switching to Combination OPT-302 With Aflibercept From Prior Anti-VEGF-A Monotherapy in Eyes With Persistent Diabetic Macula Edema (DME)

In a phase 1b study presented virtually during ASRS 2020, investigators found a reduction in central subfield thickness after 12 weeks of OPT-302 combined with aflibercept injections.

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