Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion

Phase 4

Completed

Conditions: Branch Retinal Vein Occlusion

Interventions: Drug: pegaptanib sodium (Macugen)

Registration Number: NCT00406107

Lead Sponsor: Palmetto Retina Center, LLC

Brief Summary: The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.

Detailed Description: Retinal venous occlusive disease, which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), is second only to diabetic retinopathy as a cause of vision loss due to retinal disease. The main cause of vision loss in all of these disorders is the development of macular edema. Current clinical practice based on randomized controlled clinical trials (ETDRS, BVOS) employs laser photocoagulation, either in a focal or grid pattern, to treat macular edema associated with diabetic retinopathy and branch retinal vein occlusion. Unfortunately, laser photocoagulation is ineffective in central retinal vein occlusion (CRVO), and no proven therapy exists for CRVO.

The pathogenesis of macular edema in retinal vascular diseases is generally accepted to be increased levels of vascular endothelial growth factor (VEGF) due to ischemic or other stimuli. VEGF is known to be one of the most potent stimulators of vascular leakage in humans. Therefore, it seems sensible to study inhibition of VEGF to reduce vascular leakage, reduce macular edema, and improve vision in these retinal vascular disorders.

Phase 2 randomized, controlled clinical trials of Macugen in diabetic macular edema and in macular edema associated with CRVO have been conducted. In the diabetes trial, patients treated with Macugen had improved vision, reduced macular edema as measured by optical coherence tomography (OCT), and reduced need for laser treatment compared to patients treated with sham injections. In the CRVO trial, patients treated with Macugen 1 mg every 6 weeks for 24 weeks had improved vision and reduced macular edema at week 30 compared to sham. This is the first randomized trial of treatment for CRVO to show a benefit over control. Based on these positive findings, we plan to study Macugen treatment of macular edema due to BRVO.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age
Duration of BRVO macular edema less than 6 months prior to baseline visit
Best corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method.
Central foveal thickness greater than or equal to 250 microns using the OCT-3
Less than 25% of foveal capillary ring disruption
Less than 2 disc areas of capillary non-perfusion within 1000 microns of the foveal center
Absence of hemorrhage or lipid in the foveal center
Investigator comfortable deferring macular laser for 18 weeks from baseline and intravitreous steroid for 36 weeks from baseline

Exclusion Criteria

Ocular conditions other than BRVO related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor.
Intraocular surgery within past 3 months
Significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 microns of foveal center.
Likelihood of evidence driven indication for peripheral photocoagulation in the next 6 months.
Patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of >15 letters of vision or thinning of the Center Point on OCT of >20% from baseline determination
Prior grid laser within 4 months of baseline or more than one prior grid laser treatment.
No prior intravitreous or periocular steroid injections in the study eye.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegaptanib Sodium 1 mg (Macugen)	pegaptanib sodium (Macugen)	Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
Pegaptanib Sodium 0.3mg (Macugen)	pegaptanib sodium (Macugen)	Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.

Primary Outcome Measures

Name	Time	Method
Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks	54 Weeks

Secondary Outcome Measures

Name	Time	Method
Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield	54 Weeks
Safety Parameters	54 Weeks	Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug.
Change in Central Subfield Thickness on OCT From Baseline to Week 54	54 Weeks
Change in Macular Volume on OCT From Baseline to Week 54	54 Weeks

Trial Locations

Locations (3): Jules Stein Eye Institute
🇺🇸
Los Angeles, California, United States
Cumberland Valley Retina Center
🇺🇸
Hagerstown, Maryland, United States
Palmetto Retina Center
🇺🇸
West Columbia, South Carolina, United States