Jennifer DiSanto

According to the results of a recent study, a “treat and extend” regimen (TER) of anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections in patients with neovascular age-related macular degeneration (nAMD) can help prevent serious and long-term loss of vision.

These regimens can also ensure the maintenance of visual acuity levels that can keep patients self-sufficient in real-world scenarios, such as driving, reading, and recognizing faces. Without that independence, patients have an increased risk of falling, depressive symptoms, and earlier admission to nursing homes.

The authors of the study, led by Polona Jaki Mekjavic, MD, an ophthalmologist and professor at the Eye Hospital University Medical Center at the University of Ljubljana, set out to examine the long-term efficacy of anti-VEGF treatment using TER in nAMD patients. They also wanted to identify the percentage of patients who experienced adequate visual acuity for independent functioning after treatment.

Their study was a retrospective, single-center evaluation of 101 nAMD patients treated using these methods over the course of 5 years. Participants consisted of 25 men and 76 women, ranging in age from 66 to 97 years. The study was conducted at the University Medical Center at the University of Ljubljana, in Slovenia.

Their best-corrected visual acuity (BVCA) was measured at baseline, using Early Treatment Diabetic Retinopathy Scale (ETDRS) letters, with baseline mean being 60.5 ±11.3. They were then measured once per year for the duration of the study. Study participants received monthly treatment injections of either ranibizumab (0.5 mg/0.05 mL) or bevacizumab (1.25 mg/0.05 mL). A third group of patients was treated with aflibercept (2 mg/0.05 mL), either because of a change in reimbursement policies or if the treating clinician noted a lack of treatment response.

Monthly injections continued until the patients exhibited no further signs of choroidal neovascularization (CNV), including hemorrhage or an increase in or persistence of intra-retinal or sub-retinal fluid. Presence of CNV was determined by examining the patients’ fundus and via SD-OCT imaging, and reported using ETDRS charts. If there was no CNV detected, the treatment interval was extended in 2-week intervals, up to 14 weeks. If CNV activity continued, the treatment interval was shortened by 2 weeks.

“The strength of our study is that it assessed long-term visual outcomes of anti-VEGF agents in a real-world setting,” the authors wrote. “All patients were treatment naïve, and all were treated with the TER regimen. They received treatment from clinical practice in a single eye center. This allowed us to have the same recommendations for starting treatment, the same method for measuring VA, and the same management criteria; however, this may limit the generalizability of the study findings.”

According to Mekjavic and colleagues, patients experienced improvement in visual acuity after 1 year of treatment, to 67.3 ±10.6 (

 <.05). Over the next 4 years, visual acuity declined, but was still significantly improved over baseline (second year, 66.4 ±11.7; 

 <.05; fourth year, 61.4 ±13.0; non-significant). During the final year, visual acuity returned to near-baseline levels (58.6 ±18.3).

“The study demonstrates the success of the TER approach (maintaining continuous anti-VEGF therapy and adjusting injection intervals to the patients’ responses) in preventing severe visual loss due to nAMD,” the authors continued. “Our study confirmed that patients with better baseline VA preserved good vision after long-term treatment. Further studies are warranted to determine how to maximize the proportion of eyes that will maintain good VA in long-term treatment of nAMD with anti-VEGF.”

Outcome of 5-Year Treatment of neovascular age-related Macular Degeneration With intravitreal anti-VegF Using “Treat and extend” regimen

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These regimens can also ensure the maintenance of visual acuity levels that can keep patients self-sufficient in real-world scenarios, such as driving, reading, and recognizing faces.

Treat-and-Extend Regimen Proves Preventive of Long-Term Vision Loss in AMD

According to the results of a recent post hoc analysis for the RIDE and RISE studies, participants who had diabetic macular edema (DME) and concurrent baseline macular nonperfusion (MNP) experienced improved outcomes when treated with ranibizumab.

Despite these patients having worse vision and more central subfield thickness (CST) than participants without baseline MNP upon entering the trials, they still benefited from the treatment, including increased visual acuity along with improvements in anatomy.

“When we initiated this study, we intended to investigate ranibizumab and its effect not only on [DME] but more specifically on those patients with central ischemia and [DME],” lead author Rahul Reddy, MD, MHS, the director of Clinical Trials and the fellowship director at the Associated Retinal Consultants of Phoenix, told 

. “Conventional teaching was that, in this subgroup, the clinical results may not be as good as those without ischemia, and perhaps an aggressive course of treatment may not be warranted.”

Reddy, also an assistant clinical professor at University of Arizona School of Medicine, and his team analyzed the 2 studies in an attempt to determine if patients with concurrent DME and MNP who were treated with ranibizumab experienced favorable outcomes in best corrected visual acuity (BVCA), anatomy, and diabetic retinopathy compared with patients who entered the studies without concurrent MNP at baseline.

Patients were tracked over a period of 2 years to follow their results post the RIDE and RISE trials—both phase 3, randomized, parallel, double-masked, and multicenter. These patients had the and fluorescein angiogram at baseline. The analysis looked at visual acuity, MNP area, and CST at 1 year and then again at 2 years. They also examined the incidence of ≥2-step diabetic retinopathy improvement in the eyes at 3, 6, 12, 18, and 24 months.

“Our analysis returned a very interesting result: It actually demonstrated that those eyes with ischemia gained more vision than those eyes without ischemia, which goes against conventional thinking and may change practice patterns,” Reddy explained. “This highlights 2 important points: First, we may not fully understand what macular ischemia is. This will likely be delineated in the near future with our new OCT technology. Second, we may want to be aggressive with treatment in that patient population as they may have significant vision to gain.”

Patients’ MNP was measured by laying the Early Treatment for Diabetic Retinopathy Study (ETDRS) grid over the macular fluorescein angiograms. The authors determined the estimated percentage of capillary loss in the inner, outer, and central subfields to determine the MNP and then using an algorithm to convert it into disc areas.

According to their results, 28.2% of patients in the ranibizumab 0.3-mg group (n = 213) had baseline MNP, along with 25.8% in the ranibizumab 0.5-mg arm (n = 225), and 26.3% in the sham arm (n = 225). The patients with baseline MNP tended to be younger, and also began with shorter duration of diabetes, higher CST, worse severity of DR, and worse vision compared with patients without MNP (

Patients in the ranibizumab 0.3-mg group had lower BCVA at baseline (53.4 vs. 57.2 EDTRS letters; 

 = .05). Although, they experienced a comparable gain in BCVA after 24 months (+15.6 vs. +13.4 EDTRS letters; 

At the end of 24 months, the eyes with MNP at baseline had reduced CST, even though they’d had higher CST at baseline. In all groups, eyes with MNP experienced a higher improvement in ≥2-step diabetic retinopathy compared with eyes without MNP in all study groups.

Reddy concluded that “the study was retrospective in nature; however, it gives credence to the need for further studies designed to answer this question.”

Efficacy of Ranibizumab in Eyes with Diabetic Macular Edema and Macular Nonperfusion in RIDE and RISE

Despite having worse vision and more CST than participants without baseline MNP upon entering the trials, patients experienced increased visual acuity along with improvements in anatomy.

Ranibizumab Shows Improved Outcomes for Patients with Concurrent DME, Macular Nonperfusion

Results of a recent study in Egypt indicate that using prophylactic non-steroidal anti-inflammatory drugs (NSAIDs) pre- and post-cataract surgery may help reduce the severity and frequency of the development of cystoid macular edema (CME) in the eyes of diabetic patients.

In this prospective, comparative, randomized clinical trial, the researchers aimed to determine how prophylactic, topical NSAIDs affected the development of CME, and to evaluate differences between specific NSAIDs, specifically ketorolac tromethamine 0.4% and nepafenac 0.1%.

Study participants were divided into 3 groups: the first was a placebo group, in which patients were given artificial tears product (n = 40); the second group was managed with topical nepafenac 0.1% (n = 20); and in the third group, the patients were administered topical ketorolac tromethamine 0.4% (n = 20). The participants were evaluated at 1 week, then again at 1, 2, and 3 months following their cataract surgery to check for the development of CME.

The researchers were looking at best corrected visual acuity (BCVA) as well as any changes in central macular thickness (CMT), which they evaluated using optical coherence tomography. Macular thickening is a noted common complication of cataract surgery, even routine surgeries.

At the 3-month check-in, the authors observed a statistically significant difference between the control group and both NSAID groups (

= .04). CMT had increased in all 3 groups between the 1-week check-in and the 3-month check-in (

= .004, respectively). There was no difference observed in BCVA or CMT between the ketorolac and nepafenac groups.

“My results make me sure about the effect of NSAIDs in the prevention of postoperative macular edema,” the study’s lead author, Ahmed A. Alnagdy, MD-candidate, told 

. “No cases of clinical CME (increased CMT >40 µm from preoperative baseline) were detected in the groups who received NSAIDs. In contrast, clinical CME was detected in 10% of the patients in the control group.”

“We can extrapolate our regimen to include all patients planned for cataract surgery starting 2 days preoperative and continued for 2 months as synergism with standard postoperative topical steroids,” Algnady added.

The study was conducted at the University from December 2015 to January 2017. The study included a total of 80 eyes from 76 patients. Patients were diabetic and were scheduled for extraction surgery for senile immature cataracts. The authors also reported no adverse effects related to the use of NSAIDs.

“Also, NSAIDs prevent intraoperative miosis during cataract surgeries,” said Alnagdy, who serves on the Faculty of Medicine at the Mansoura Ophthalmic Center, Mansoura University, Egypt. “Which decreases the risk of intraoperative complications and decreases pain, especially in topical and local anesthesia, which makes me start NSAIDs as routine preoperative. Thirty percent of patients in the control group had an intraoperative poorly dilated pupil, with no cases detected in the NSAID groups.”

Alnagdy concluded that the “study found no significant difference between two NSAID medications used [nepafenac and ketorolac]. In my work, I prefer using nepafenac 0.1%, 3 times a day, because patients become more comfortable with this less frequent use.”

Impact of topical nonsteroidal anti-inflammatory drugs in prevention of macular edema following cataract surgery in diabetic patients

Researchers aimed to determine how prophylactic, topical NSAIDs affected the development of CME, specifically ketorolac tromethamine 0.4% and nepafenac 0.1%.

NSAIDs May Reduce Incidence of Macular Edema Following Cataract Surgery

The risk for chronic obstructive pulmonary disease (COPD), arthritis, and cardiovascular disease can be increased by patient’s psychological distress, even if their distress is considered low or moderate, according to a recent study.

“Psychological distress” is a term that encompasses a wide range of anxiety and depression symptoms, from mild to severe. The authors say these symptoms have been associated with an increased risk of many chronic health conditions, as well as with all-cause mortality.

Author Catharine Gale, BSc, PhD, a professor of cognitive epidemiology in the MRC Lifecourse Epidemiology Unit at the University of Southampton, at Southampton General Hospital told MD 

, “Our findings show that even low levels of psychological distress, below the level usually considered clinically significant, appear to increase the risk of arthritis, chronic lung disease, and cardiovascular disease.” 

Gale and her colleagues set out to assess the links between psychological distress and socioeconomic position for 4 diseases: diabetes, arthritis, COPD, and cardiovascular disease. They selected these 4 particular conditions to study because while the association with “significant distress” and these diseases has been well established, the evidence of their connection to subclinical distress levels demonstrated “a significant gap in knowledge.”

They also took into account the severity of the patient’s distress, health habits that would affect risk (e.g., diet, exercise, smoking), and variations based on socioeconomic status.

The study collected data from 16,485 adults who had participated in the UK Household Longitudinal Study, which had gathered data on economic, social, psychological, and health from a large sample of participants from various social, economic, and ethnic backgrounds.

In this study, patients’ baseline psychological distress was reported on the General Health Questionnaire (GHQ), and they self-reported their experience with the four disorders over the past 3 years. The GHQ asks users to rate the frequency of their experience with 12 common symptoms, including loss of confidence and sleep disruptions. The study was also designed to control for age, sex, body mass index, baseline disease, and social support, including marital status and neighborhood cohesion.

The participants’ socioeconomic position was based on occupation, including most recent occupation if the participant was not employed. They were categorized using the Registrar General’s Social Class, which ranges from “professional occupation” to “unskilled occupation.” The participants were then further divided into “non-manual” and “manual” occupational classes.

The authors concluded that there was a dose-response pattern of psychological distress associated with significantly increased risk for COPD, cardiovascular disease, and arthritis. Patients with high distress levels—in this case, a score of 7 or higher on the GHQ&mdash;were said to be at an increased risk for COPD (odds ratio [OR], 3.25; 95% CI, 1.47 to 7.18), and cardiovascular disease (OR 3.06; 95% CI, 1.89 to 4.98) arthritis (OR 2.22; 95% CI, 1.58 to 2.13). Participants’ smoking status affected the association, but it remained significant after accounting for smoking, as well as exercise and eating habits.

“This implies that interventions to reduce symptoms of anxiety and depression may help to prevent these diseases,” Gale said.

The risk for diabetes was increased significantly only for participants in the “manual” occupational group, as opposed to “non-manual.” The authors did not report any socioeconomic effect on risk for arthritis, COPD, or cardiovascular disease.

The effects of psychological distress and its interaction with socioeconomic position on risk of developing four chronic diseases

There was a dose-response pattern of psychological distress associated with significantly increased risk for COPD, cardiovascular disease, and arthritis.

Jennifer DiSanto

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