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

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.

Study Overview

• Status: Completed
• Conditions: Retinal Ischemia
• Intervention / Treatment: Procedure: Panretinal Photocoagulation; Procedure: Panretinal Photocoagulation and intravitreal injection of 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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Southern New England Retina Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Panretinal Photocoagulation	Procedure: Panretinal Photocoagulation; Panretinal Photocoagulation treatment
Active Comparator: 2; Ranibizumab Supplementing Panretinal Laser Photocoagulation	Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab; Panretinal photocoagulation and ranibizumab; Other Names: laser and Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
The mean change in best corrected visual acuity score	1 to 12 months
The percentage/number of patients that experience vision loss of 30 letters or less	1 to 12 months
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 macular thickness on OCT	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

Collaborators and Investigators

• Sponsor: Southern New England Retina Associates
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Magdalena G Krzystolik, MD, Southern New England Retina Associates

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 10, 2009
• First Submitted That Met QC Criteria: February 10, 2009
• First Posted (Estimate): February 11, 2009

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Retinal ischemia: Iris/Angle Neovascularization
• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Ischemia; Neovascularization, Pathologic; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: 100,611