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

Retinal Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841373
• Other study ID #: 100,611
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 10, 2009
• Last updated: November 17, 2014
• Start date: July 2007
• Est. completion date: January 2010

Study information

• Verified date: November 2014
• Source: Southern New England Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Retinal Ischemia

Intervention

Procedure:
• Panretinal Photocoagulation
Panretinal Photocoagulation treatment
• Panretinal Photocoagulation and intravitreal injection of ranibizumab
Panretinal photocoagulation and ranibizumab

Locations

Country	Name	City	State
United States	Southern New England Retina Associates	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Southern New England Retina Associates	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam.		1 to 12 months	Yes
Primary	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	No
Secondary	The mean change in best corrected visual acuity score		1 to 12 months	No
Secondary	The percentage/number of patients that experience vision loss of 30 letters or less		1 to 12 months	No
Secondary	The percentage number of patients that experience vision improvement of more than 15 letters		1 to 12 months	No
Secondary	The percentage/number of patients whose vision progressed to no light perception		1 to 12 months	No
Secondary	The mean change in macular thickness on OCT		1 to 12 months	No
Secondary	The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision		1 to 12 months	No
Secondary	The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure		1 to 12 months	No