Ingrid Zimmer-Galler

Ranibizumab for macular edema due to retinal vein occlusions: implication of VEGF as a critical stimulator.

Macular edema is a major cause of vision loss in patients with central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO). It is not clear how much of the edema is due to hydrodynamic changes from the obstruction and how much is due to chemical mediators. Patients with macular edema due to CRVO (n = 20) or BRVO (n = 20) were randomized to receive three monthly injections of 0.3 or 0.5 mg of ranibizumab. At the primary endpoint, month 3, the median improvement in letters read at 4 m was 17 in the 0.3-mg group and 14 in the 0.5-mg group for CRVO, and 10 and 18, respectively for the BRVO group. Optical coherence tomography (OCT) showed that compared to injections of 0.3 mg, injections of 0.5 mg of ranibizumab tended to cause more rapid reductions of central retinal thickening that lasted longer between injections, but in 3 months, excess central retinal thickening which is a quantitative assessment of the macular edema, was reduced by approximately 90% in all four treatment groups. There was no correlation between the amount of improvement and duration of disease or patient age at baseline, but there was some correlation between the aqueous vascular endothelial growth factor (VEGF) level at baseline and amount of improvement. These data indicate that excess production of VEGF in the retinas of patients with CRVO or BRVO is a major contributor to macular edema and suggest that additional studies investigating the efficacy of intraocular injections of ranibizumab are needed.

TeleHealth Improves Diabetes Self-Management in an Underserved Community: Diabetes TeleCare

OBJECTIVE To conduct a 1-year randomized clinical trial to evaluate a remote comprehensive diabetes self-management education (DSME) intervention, Diabetes TeleCare, administered by a dietitian and nurse/certified diabetes educator (CDE) in the setting of a federally qualified health center (FQHC) in rural South Carolina. RESEARCH DESIGN AND METHODS Participants were recruited from three member health centers of an FQHC and were randomized to either Diabetes TeleCare, a 12-month, 13-session curriculum delivered using telehealth strategies, or usual care. RESULTS Mixed linear regression model results for repeated measures showed a significant reduction in glycated hemoglobin (GHb) in the Diabetes TeleCare group from baseline to 6 and 12 months (9.4 ± 0.3, 8.3 ± 0.3, and 8.2 ± 0.4, respectively) compared with usual care (8.8 ± 0.3, 8.6 ± 0.3, and 8.6 ± 0.3, respectively). LDL cholesterol was reduced at 12 months in the Diabetes TeleCare group compared with usual care. Although not part of the original study design, GHb was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group (9.2 ± 0.4, 7.4 ± 0.5, and 7.6 ± 0.5, respectively) compared with usual care (8.7 ± 0.4, 8.1 ± 0.4, and 8.1 ± 0.5, respectively) in a post hoc analysis of a subset of the randomized sample who completed a 24-month follow-up visit. CONCLUSIONS Telehealth effectively created access to successfully conduct a 1-year remote DSME by a nurse CDE and dietitian that improved metabolic control and reduced cardiovascular risk in an ethnically diverse and rural population.

Comparison Between Retinal Thickness Analyzer and Optical Coherence Tomography for Assessment of Foveal Thickness in Eyes With Macular Disease

PURPOSE To use the retinal thickness analyzer (RTA) and optical coherence tomography (OCT) scanners for quantitative measurement of retinal thickness in eyes with macular disease. DESIGN In a cross-sectional study, 44 patients (55 eyes) with macular disease and sufficient media clarity to visualize the fundus using clinical biomicroscopy underwent an ophthalmologic examination, fluorescein angiography, RTA, and OCT during the same visit. METHODS Foveal and foveal center (foveolar) retinal thickness measurements were obtained by RTA and by OCT. RESULTS Retinal thickness measurements were obtained by OCT in all 55 eyes and by RTA in 34 eyes (62%, primarily due to interference from media opacities). In the 34 eyes in which measurements were obtained by both instruments, mean foveal thickness was 291 and 269 microm for OCT and RTA, respectively; foveolar thickness was 277 and 265 microm, respectively. OCT and RTA measurements of foveal thickness were strongly correlated (intraclass correlation coefficient = 0.89), as were measurements of the foveolar thickness (intraclass correlation coefficient = 0.94). Topographic maps generated by the two techniques yielded qualitatively similar information. CONCLUSIONS Overall, there was excellent agreement between RTA and OCT measurements. Each technique has advantages that may make its use preferable in a particular subgroup of eyes or to describe a particular disease process. An important consideration is that media opacities create less interference for OCT than for RTA, so that in study populations with a moderate-to-high prevalence of media opacity, images can be obtained in a greater percentage of eyes by OCT than by RTA.

Retinal Thickness Analysis by Race, Gender, and Age Using Stratus OCT

PURPOSE To detect differences in retinal thickness among patients of different race, gender, and age using Stratus OCT. DESIGN Cross-sectional study. METHODS In a multicenter, university-based study, 126 patients with no history of ocular disease were enrolled (78 diabetics without retinopathy and 48 nondiabetics). Optical coherence tomography measurements were performed using Stratus OCT. Statistical comparisons of center point foveal thickness and mean foveal thickness were made using generalized estimating equations adjusting for diabetic status, race, age, and gender. RESULTS The study population consisted of 36% male subjects, 39% Caucasian, 33% African-American, and 28% Hispanic. Mean foveal thickness was 191.6 +/- 2.7 microm and 194.5 +/- 2.7 microm for diabetics and nondiabetics, respectively (P = .49). Mean foveal thickness in male subjects was significantly larger than in female (201.8 +/- 2.7 microm and 186.9 +/- 2.6 microm, respectively; P < .001). Mean foveal thickness was 200.2 +/- 2.7 microm for Caucasian, 181.0 +/- 3.7 microm for African-American, and 194.7 +/- 3.9 microm for Hispanic subjects. Mean foveal thickness was significantly less for African-American than Caucasian (P < .0001) or Hispanic subjects (P = .005). Center point foveal thickness and mean foveal thickness showed a significant increase with age. CONCLUSIONS There are statistically significant differences in retinal thickness between subjects of different race, gender, and age. When compared to Caucasian and Hispanic subjects, African-American race is a predictor of decreased mean foveal thickness; and male sex (regardless of race) is a significant predictor of increased mean foveal thickness. Mean foveal thickness is similar among diabetics and nondiabetics when data are controlled for age, race, and sex. These results suggest that studies comparing OCT measurements should carefully control for age-based, race-based, and gender-based variations in retinal thickness.

Antagonism of vascular endothelial growth factor for macular edema caused by retinal vein occlusions: two-year outcomes.

PURPOSE To determine the long-term effects of intraocular antagonism of vascular endothelial growth factor (VEGF) in patients with macular edema caused by retinal vein occlusions (RVOs). DESIGN Prospective randomized trial. PARTICIPANTS Twenty patients with macular edema caused by branch RVOs (BRVOs) and 20 patients with central RVOs (CRVOs). METHODS After the month 3 primary end point, patients were seen every 2 months and received injections of an anti-VEGF agent as needed for recurrent edema. MAIN OUTCOME MEASURES Mean change from baseline best-corrected visual acuity (BCVA) at month 24 with assessment of other parameters of visual function and center subfield thickness (foveal thickness [FTH]). RESULTS For 17 patients with BRVO who completed 2 years of follow-up, the mean improvement from baseline in BCVA at month 24 was 17.8 letters compared with 15.6 letters at month 3. Improvement by at least 6, 3, or 2 lines occurred in 18%, 59%, and 76% of patients, respectively. The Snellen equivalent BCVA at month 24 was 20/40 or better in 10 patients. With an average of 2 injections of ranibizumab during year 2, the mean FTH at month 24 was 245.8 μm compared with 217.1 μm at month 3 and 481.5 μm at baseline. For 14 patients with CRVO who completed 2 years of follow-up, the mean improvement in BCVA at month 24 was 8.5 letters compared with 12.0 letters at month 3. Improvement by at least 6, 3, or 2 lines occurred in 14%, 21%, and 43% of patients, respectively. The Snellen equivalent BCVA at month 24 was 20/40 or better in 4 patients. With an average of 3.5 injections of ranibizumab in year 2, mean FTH at month 24 was 338 μm compared with 278 μm at month 3 and 533 μm at baseline. Duration of RVO >1 year at study entry and nonperfusion of perifoveal capillaries for 360 degrees correlated with reduced visual outcomes. CONCLUSIONS Antagonism of VEGF provides substantial long-term benefit to patients with macular edema caused by RVO, but frequent injections are required in some patients with BRVO and most patients with CRVO.

Telehealth practice recommendations for diabetic retinopathy, second edition.

Ocular telemedicine and telehealth have the potential to decrease vision loss from DR. Planning, execution, and follow-up are key factors for success. Telemedicine is complex, requiring the services of expert teams working collaboratively to provide care matching the quality of conventional clinical settings. Improving access and outcomes, however, makes telemedicine a valuable tool for our diabetic patients. Programs that focus on patient needs, consider available resources, define clear goals, promote informed expectations, appropriately train personnel, and adhere to regulatory and statutory requirements have the highest chance of achieving success.

Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion The RELATE Trial

PURPOSE To determine whether scatter and grid laser photocoagulation (laser) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion (RVO) and to compare 0.5-mg with 2.0-mg ranibizumab. DESIGN Randomized, double-masked, controlled clinical trial. PARTICIPANTS Thirty-nine patients with central RVO (CRVO) and 42 with branch RVO (BRVO). METHODS Subjects were randomized to 0.5 mg or 2.0 mg ranibizumab every 4 weeks for 24 weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone. MAIN OUTCOME MEASURES Mean change from baseline best-corrected visual acuity (BCVA) at week 24 for BCVA at weeks 48, 96, and 144 for second randomization. RESULTS Mean improvement from baseline BCVA at week 24 was 15.5 and 15.8 letters in the 0.5-mg and 2.0-mg CRVO groups, and 12.1 and 14.6 letters in the 0.5-mg and 2.0-mg BRVO groups. For CRVO, but not BRVO, there was significantly greater reduction from baseline mean central subfield thickness (CST) in the 2.0-mg versus 0.5-mg group (396.1 vs. 253.5 μm; P = 0.03). For the second randomization in CRVO patients, there was no significant difference from week 24 BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week 48 (-3.3 vs. 0.0 letters), week 96 (+0.69 vs. -1.6 letters), or week 144 (+0.4 vs. -6.7 letters), and a significant increase from week 24 mean CST at week 48 (+94.7 vs. +15.2 μm; P = 0.05) but not weeks 96 or 144. For BRVO, there was a significant reduction from week 24 mean BCVA in ranibizumab plus laser versus ranibizumab at week 48 (-7.5 vs. +2.8; P < 0.01) and week 96 (-2.0 vs. +4.8; P < 0.03), but not week 144, and there were no differences in mean CST change from week 24 at weeks 48, 96, or 144. Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks 24 and 144. CONCLUSIONS In patients with macular edema resulting from RVO, there was no short-term clinically significant benefit from monthly injections of 2.0-mg versus 0.5-mg ranibizumab injections and no long-term benefit in BCVA, resolution of edema, or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab.

Long-term Outcomes in Ranibizumab-Treated Patients With Retinal Vein Occlusion; The Role of Progression of Retinal Nonperfusion

PURPOSE To determine the percentage of ranibizumab-treated patients with retinal vein occlusion (RVO) who had resolution of edema for at least 6 months after the last injection, along with factors and outcomes that correlate with resolution. DESIGN Post hoc analysis of open-label clinical trial. METHODS Twenty patients with branch RVO (BRVO) and 20 with central RVO (CRVO) received ranibizumab monthly for 3 months and as needed for recurrent/persistent macular edema, no more frequently than every 2 months. Patients still requiring injections after month 40 received scatter and grid laser photocoagulation to try to reduce the need for injections. Main outcome measures included the percentage of patients who had resolution of edema, change in best-corrected visual acuity (BCVA) from baseline, and change in area of retinal nonperfusion in central subfields. RESULTS Nine patients with BRVO (45%) had edema resolution from injections alone after a mean of 20.2 months, 4 resolved after addition of laser, 4 were unresolved through 72 months, and 3 exited prior to resolution. Five patients with CRVO (25%) resolved from injections alone after a mean of 14.0 months, 8 remained unresolved through 72 months despite addition of laser, and 7 exited prior to resolution. For BRVO or CRVO, there was a negative correlation between posterior retinal nonperfusion area and BCVA at months 18, 24, and 36 (P < .05). CONCLUSIONS In patients with RVO, infrequent ranibizumab injections to control edema may not be sufficient to prevent progression of retinal nonperfusion, which may contribute to loss of visual gains.

Impact of optical coherence tomography on surgical decision making for epiretinal membranes and vitreomacular traction.

Purpose: To compare retina surgeons’ recommendations for management of epiretinal membranes (ERM) and vitreomacular traction (VMT) based on clinical assessment alone with management based on clinical evaluation supplemented by optical coherence tomography (OCT). Methods: A prospective, masked clinical case series was conducted. Surgeons first performed a complete history and physical examination on patients referred with the macular disorders under study without the benefit of adjunctive OCT, determined whether ERM, VMT, and/or macular edema were present, questionably present, or absent, and made a provisional management recommendation. The retina specialists then reviewed the OCT images for the presence or absence of ERM, VMT, and/or associated macular edema and reconsidered the final management recommendation in light of clinical evaluation combined with OCT findings. Results: Eighty-four eyes of 73 patients were examined. ERM was identified in 66 (78.6%) of 84 eyes using clinical examination compared with 72 (85.7%) of 84 eyes using OCT (P = 0.06). VMT was identified in 5 (6%) of 84 eyes using clinical examination compared with 18 (21.4%) of 84 eyes using OCT (P < 0.005). Macular edema was identified in 57 (67.9%) of 84 eyes using clinical examination compared with 70 (83.3%) of 84 eyes using OCT (P = 0.003). Surgical intervention was recommended in 33 cases: 19 (57.6%) based on the history and clinical examination findings without OCT information and an additional 14 (42.4%) based on the combination of clinical evaluation and OCT findings. Conclusions: OCT is more sensitive than clinical examination in detecting ERM, VMT, and associated macular edema. Taken together with careful clinical evaluation, OCT findings influenced surgeons to recommend consideration of surgery to an additional 14 patients (42.2%) in this series.

Diabetic retinopathy screening and the use of telemedicine.

Purpose of review Evidence-based practice guidelines and treatments are highly effective in reducing vision loss from diabetic retinopathy. However, less than half of the total number of patients with diabetes mellitus receive recommended annual retinal evaluations, and vision loss due to diabetic retinopathy remains the leading cause of blindness in adults. Poor adherence to screening recommendations stems from a number of challenges which telemedicine technology may address to increase the evaluation rates and ultimately reduce vision loss. The aim of this review was to provide an update on the recent advances in tele-ophthalmology and how it may expand our current concept of eye care delivery for diabetic eye disease. Recent findings The benefits of telemedicine diabetic retinopathy are proven for large population-based systems. Outcomes information from community-based programs is now also beginning to emerge. Improved screening rates and less vision loss from diabetic retinopathy are being reported after implementation of telemedicine programs. New imaging platforms for telemedicine programs may enhance the ability to detect and grade diabetic retinopathy. However, financial factors remain a barrier to widespread implementation. Summary Telemedicine diabetic retinopathy screening programs may have a significant impact on reducing the vision complications and healthcare burden from the growing diabetes epidemic. Video abstract http://links.lww.com/COOP/A17