Ranibizumab Supplementing Panretinal Photocoagulation as Treatment for Iris/Angle Neovascularization in Retinal Ischemic Disease

Southern New England Retina Associates

Status and phase: Completed; Phase 2; Phase 1

Conditions: Retinal Ischemia

Treatments: Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab; Procedure: Panretinal Photocoagulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00841373

100,611

Details and patient eligibility

About

The object of the study is to compare treatment of iris/angle neovascularization with panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an anti-angiogenic drug: ranibizumab.

Full description

A.To obtain preliminary data on the safety and tolerability of ranibizumab (0.5 mg)in patients with new or progressive neovascularization of the iris or angle due to retinal ischemic diseases in addition to treatment with PRP using the incidence and severity of adverse events identified by subjenc reporting vital signs, and ocular examition.

B.To assess the proportion of patients who fail to experience regression of iris and angle neovascularization documented by the clinical examination, iris florescein angiography and gonioscopic evaluation.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects must meet the following criteria to be eligible for study entry:

1. Signed informed consent and authorization of use and disclosure of protected health information
2. Age = 18 years
3. Presence of iris neovascularization and or angle neovascularization due to any retinal ischemic disease that is new onset or noted to progress recently on the slit lamp examination or gonioscopy
4. Best corrected visual acuity in the study eye 20/20 (Snellen equivalent using EDTRS protocol at 4 meters) to light perception. Only one eye will be enrolled in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity in the non-study eye must be better than no light perception
5. Patient is able and willing to return for all scheduled visits

Exclusion criteria

1. Use of intraocular or periocular injection of steroids (for, example triamcinolone) in the study eye within 3 months of the study
2. Use of intraocular injection of anti-angiogenic drugs in the study eye and or participation in a clinical trial using an antiangiogenic treatment within 45 days from the enrollment in the study.
3. Acute endophthalmitis within 1 month.
4. Recent rhegmatogenous retinal detachment or macular hole surgery within last 2 months
5. Uncontrolled uveitis in the last month.
6. Treatment with PRP within 2 weeks of the study enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

1

Active Comparator group

Description:

Panretinal Photocoagulation

Treatment:

Procedure: Panretinal Photocoagulation

2

Active Comparator group

Description:

Ranibizumab Supplementing Panretinal Laser Photocoagulation

Treatment:

Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab