RETAIN: Mixed results for BRVO/CRVO with ranibizumab

January 15, 2014

The RETAIN Study of the effect of retinal vein occlusion (RVO) treated with ranibizumab injections found good visual acuity results in patients with branch RVO.

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The RETAIN Study of the effect of retinal vein occlusion (RVO) treated with ranibizumab injections found good visual acuity results in patients with branch RVO.

 

Dr. Campochiaro

By Lynda Charters; Reviewed by Peter A. Campochiaro, MD

Baltimore-The RETAIN Study demonstrated that the long-term visual outcomes in patients with retinal vein occlusion (RVO) treated with ranibizumab (Lucentis, Genentech) are very good and average visual gains obtained in the first 6 months of treatment are maintained for at least 4 years.

However, 50% of patients with branch RVO (BRVO) and 56% of patients with central RVO (CRVO) were still requiring injections of ranibizumab 4 years after initiating treatment to control edema. In most patients, RVO is a chronic disease that requires prolonged follow-up and management, according to Peter A. Campochiaro, MD, on behalf of the RETAIN Study group.

Following the BRAVO and CRUISE studies and the subsequent HORIZON studies of RVO, which showed substantial short-term treatment benefits from treatment with ranibizumab, researchers were left with unanswered questions regarding long-term outcomes: is there a time when injections would no longer be needed or is lifetime treatment necessary, will vision be maintained or lost over time, and could adjunctive treatments contribute to the maintenance of treatment benefits and reduce the need for injections?

Dr. Campochiaro, the George S. and Dolores Dore Professor of Ophthalmology and Neuroscience at Johns Hopkins University School of Medicine, Baltimore, organized the RETAIN trial. Results of the study were published in Ophthalmology Oct. 7, 2013, to address these questions.

In the RETAIN Study, 34 patients with BRVO and 32 patients with CRVO who completed the HORIZON study and were followed for another 2 years.

During year 1, patients were evaluated monthly and in year 2 at least every 3 months. When intraretinal fluid was seen on spectral-domain optical coherence tomography, patients were treated with 0.5 mg of ranibizumab. Scatter photocoagulation was applied in patients who required injections in two consecutive months. If injections were still needed 3 months after laser, supplemental scatter photocoagulation combined with grid laser photocoagulation was given.

BRVO patients

In the RETAIN Study, patients with BRVO had substantial increases in the mean best-corrected visual acuity (BCVA) at 6 months after BRAVO baseline that were well maintained at every time point over the subsequent 4 years, Dr. Campochiaro noted.

“The final mean BCVA in Snellen equivalent was 20/32,” he said.

During year 4, the patients were treated with an average of two ranibizumab injections. Half of the 34 patients with BRVO achieved resolution of macular edema for a minimum of 6 months after the last ranibizumab injection; 77% of these patients who had resolution of edema received their last injection of ranibizumab within 2 years of their first injection.

Patients who were still requiring injections 2 years after initiating treatment were unlikely to achieve resolution of edema within 4 years. Dr. Campochiaro explained. Patients with unresolved edema required a mean of 3 injections in year 4

Interestingly, the mean BCVA was 20/32 both in patients with resolved macular edema and those without resolution indicating that patients with BRVO maintain visual potential even when they have chronic, recurrent edema that requires injections for 4 years.

CRVO patients

Patients with CRVO in RETAIN also maintained the improved mean BCVA that was obtained at the month 6 endpoint of CRUISE, according to Dr. Campochiaro.

Mean foveal thickness was less stable than that seen in patients with BRVO and the final mean BCVA was 20/50. The percentage of patients with CRVO with resolved macular edema was 44%, and 71% of them achieved resolution during the first 2 years after the start of treatment.

“Unlike patients with BRVO, those with CRVO with resolved macular edema had significantly better BCVA (mean, 20/32) compared with those with unresolved edema (mean, 20/80),” he said.

Those with unresolved edema had substantially greater mean foveal thickness and required a mean of 6 injections during year 4. These patients tended to be older than those with resolved macular edema and more likely to be hypertensive, Dr. Campochiaro noted.

The loss of BCVA in these patients was due to photoreceptor damage, probably from recurrent macular edema and/or ischemic damage to the macula.

This subgroup may benefit from more sustained suppression of vascular endothelial growth factor.

 

Peter A. Campochiaro, MD

E: pcampo@jhmi.edu

Dr. Campochiaro is a consultant for Advanced Cell Technology, Aerpio, Gene Signal, Elan, Genentech, Genzyme, GlaxoSmithKline, Oxford BioMedica, and Regeneron.

 

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