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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00841373
Other study ID # 100,611
Secondary ID
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.


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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


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
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