Retinal Ischemia
Conditions
Keywords
Retinal ischemia: Iris/Angle Neovascularization
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREPanretinal Photocoagulation
Panretinal Photocoagulation treatment
PROCEDUREPanretinal Photocoagulation and intravitreal injection of ranibizumab
Panretinal photocoagulation and ranibizumab
Sponsors
Genentech, Inc.
Southern New England Retina Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam. | 1 to 12 months |
| The proportion of patients who fail to maintain regression of iris and angle neovascularization documented by the clinical examination iris fluorescein angiography and gonioscopic evaluation. | 1 to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| The percentage number of patients that experience vision improvement of more than 15 letters | 1 to 12 months |
| The percentage/number of patients whose vision progressed to no light perception | 1 to 12 months |
| The mean change in best corrected visual acuity score | 1 to 12 months |
| The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision | 1 to 12 months |
| The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure | 1 to 12 months |
| The mean change in macular thickness on OCT | 1 to 12 months |
| The percentage/number of patients that experience vision loss of 30 letters or less | 1 to 12 months |
Countries
United States
Outcome results
None listed