Latest in retinal research results dominate ARVO annual meeting

FORT LAUDERDALE, Fla. — The Association for Research and Vision in Ophthalmology meeting had a heavy emphasis on major retina studies that are either currently under way or about to be.

The following represents some of the retinal news reported by Primary Care Optometry News and Ocular Surgery News from the meeting. Most of these news items appeared as live coverage at PCONSupersite and OSN SuperSite.com.

Look to upcoming issues of PCON for more coverage of these and other topics of interest from the ARVO meeting.

SUMMIT will evaluate verteporfin and ranibizumab for wet AMD

A series of international trials are scheduled to be launched to assess the safety and efficacy of combined verteporfin and ranibizumab for subfoveal choroidal neovascularization due to age-related macular degeneration.

Jason S. Slakter, MD, outlined the trials in a poster presentation. The SUMMIT program will comprise two randomized, controlled trials: DENALI in the United States and Canada and MONT BLANC in Europe. Dr. Slakter is heading the DENALI study group.

Inclusion criteria for DENALI and MONT BLANC include age of 50 years or older, presentation of any type of subfoveal CNV secondary to AMD, lesion size less than 9 disc areas, resistance to AMD treatment and Snellen best corrected visual acuity of 20/40 to 20/30.

The 2-year DENALI study will include 318 patients. The 1-year MONT BLANC study will include 250 patients.

DENALI will comprise two combination treatment study arms.

The first arm will involve a standard or reduced dose of verteporfin at baseline plus intravitreal injection of 0.5 mg ranibizumab at baseline and months 1 and 2, followed from month 3 by ranibizumab as needed and verteporfin standard or reduced fluence as needed, according to the poster.

The second arm will comprise monthly 0.5 mg of ranibizumab monotherapy.

MONT BLANC will also include two arms. The first arm will involve 0.5 mg of ranibizumab plus a standard dose of verteporfin. The control arm will involve 0.5 mg of ranibizumab and placebo, the poster indicated. Patients will receive ranibizumab at baseline, 1 and 2 months and monthly as required. Combined verteporfin or “sham” verteporfin will be given at baseline and on a quarterly basis from months 3 to 11.

“Results from the SUMMIT program will provide important insight into the efficacy, safety, treatment practice and health economics outcomes of verteporfin therapy administered in combination with ranibizumab in patients with wet AMD,” the poster said.

The trials are designed to “demonstrate that combination therapy is not inferior to ranibizumab monotherapy at 12 months after the start of treatment, based on best corrected visual acuity measurements,” the poster said.

Ranibizumab, PDT combination successfully treats neovascular AMD

Combined treatment with intravitreal ranibizumab and verteporfin photodynamic therapy is more effective against neovascular age-related macular degeneration than photodynamic therapy alone, according to study data presented here.

Paolo Lanzetta, MD, of the University of Udine, Italy, discussed results of the phase 1/2 FOCUS study.

The trial randomly assigned 162 patients to undergo Visudyne (verteporfin, Novartis) PDT combined with either monthly 0.5-mg injections of Lucentis (ranibizumab, Genentech) or sham injections.

The ranibizumab group included 106 patients, and the PDT-only group included 56 patients. In both groups, surgeons performed PDT 7 days before the first ranibizumab or sham injection. Patients in both groups then received treatment with PDT every 3 months as needed, Dr. Lanzetta said.

Investigators found that the sham injection group had a 93% PDT re-treatment rate and required an average of three additional PDT sessions. Patients treated with PDT combined with ranibizumab had a 33% re-treatment rate and required an average of 0.4 additional PDT sessions, he said.

“At 24 months, combination therapy reduced vision loss of more than 15 letters compared to verteporfin PDT alone, increased mean visual acuity over baseline, reduced progression to 20/200 and the need for PDT re-treatment,” Dr. Lanzetta said.

Visual acuity improved an average of five letters over baseline for the combination treatment group and decreased an average of eight letters for the PDT-only group, he said.

Pegaptanib effective as ‘maintenance therapy’ in wet AMD patients, study shows

Pegaptanib injections were effective in maintaining visual and anatomical stability in wet AMD patients who began treatment with other agents, according to Thomas R. Friberg, MD, MS.

Dr. Friberg presente d interim results from the phase 4 LEVEL (Evaluation of Efficacy and Safety in Maintaining Visual Acuity with Sequential Treatment of Neovascular AMD) trial. The study included two phases, he said — an “induction phase,” in which patients received Lucentis (ranibizumab, Genentech), Avastin (bevacizumab, Genentech), other agents, and a “maintenance phase,” during which patients received 0.3-mg injections of Macugen (pegaptanib, OSI/Eyetech) injections every 6 weeks. Only those patients who experienced significant clinical improvement in the induction phase moved on to the maintenance phase.

A total of 83 patients completed 24 weeks of Macugen treatment. From induction to week 24, more than 80% of patients gained zero or more lines of vision, almost 40% gained at least three lines of vision, and 96% lost less than three lines of visual acuity. Optical coherence tomography measurements showed that center point thickness remained stable. Visual and anatomical results were similar in 163 patients who completed 18 months follow-up.

According to the study protocol, patients received “booster” pegaptanib treatments if they lost two or more lines, had a center point retinal thickness of 300 µm or greater or experienced an increase of 100 µm of retinal thickness from enrollment. After 24 weeks of treatment, 59% of patients had not received booster treatments, and of those who did, 76% received only one booster treatment.

At 24 weeks, safety results were consistent with the VISION trial. There was no increased risk of hypertension, nonocular hemorrhages, cardiovascular or thromboembolic events, endophthalmitis, retinal detachment or traumatic cataract.

The study will track patients for a total of 54 weeks of follow-up.

Same-day ranibizumab, PDT treatments may reduce need for further PDT, retinal thickness

Same-day administration of verteporfin PDT and ranibizumab 0.5 mg was not associated with severe vision loss and appeared to reduce the number of further verteporfin PDT treatments required, according to one ophthalmologist.

Frank G. Holz, MD, presented these conclusions from the PROTECT study here. The study included 32 patients with classic or occult lesions randomized into three cohorts. Visudyne PDT was administered at baseline and at 3, 6 and 9 months if fluorescein angiography showed leakage. Lucentis 0.5 mg was administered within 1 hour of verteporfin at baseline and then monthly for 3 months.

The results showed that only one patient experienced moderate vision loss, and mean visual acuity improved 2.4 letters at 9 months. Of the 32 patients, 69% only needed the initial dose of PDT, 22% required one additional dose, and 9% needed the maximum number of treatments.

In another study, researchers showed that same-day treatment with ranibizumab 0.5 mg and verteporfin PDT reduced retinal thickness significantly at 1 month.

As part of the PROTECT study, Sebastian Wolf, MD, PhD, and colleagues evaluated the effects of the combination treatment on 32 patients with predominantly classic or occult lesions.

Results showed that, at baseline, 26 of 28 patients with OCT measurements had intraretinal edema. At 1 month, retinal thickness had decreased by an average of 173 µm from an average baseline measurement of 404 µm. The decrease was maintained throughout the study.

A note from the editors:

To facilitate bringing news to readers rapidly, for PCON SuperSite articles and meeting wrap-up articles, PCON departs from its editorial policy and typically does not send these items out for source corrections. This article also appeared in Ocular Surgery News, a sister publication of PCON.