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

NCT00841373 | Completed Phase 1 DMC

• 1 other identifier: 100,611
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Ischemia

Keywords

Retinal ischemia: Iris/Angle Neovascularization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Panretinal Photocoagulation

Procedure: Panretinal Photocoagulation

2

ACTIVE COMPARATOR

Ranibizumab Supplementing Panretinal Laser Photocoagulation

Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab

Interventions

Panretinal Photocoagulation PROCEDURE

Panretinal Photocoagulation treatment

1

Panretinal Photocoagulation and intravitreal injection of ranibizumab PROCEDURE

Panretinal photocoagulation and ranibizumab

Also known as: laser and Lucentis

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must meet the following criteria to be eligible for study entry:
• Signed informed consent and authorization of use and disclosure of protected health information
• Age = 18 years
• 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
• 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
• Patient is able and willing to return for all scheduled visits

You may not qualify if:

• Use of intraocular or periocular injection of steroids (for, example triamcinolone) in the study eye within 3 months of the study
• 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.
• Acute endophthalmitis within 1 month.
• Recent rhegmatogenous retinal detachment or macular hole surgery within last 2 months
• Uncontrolled uveitis in the last month.
• Treatment with PRP within 2 weeks of the study enrollment.

Sponsors & Collaborators

• Southern New England Retina Associates: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Southern New England Retina Associates

Providence, Rhode Island, 02904, United States

Location

MeSH Terms

Interventions

Lasers; Ranibizumab

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Magdalena G Krzystolik, MD

  Southern New England Retina Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Madgalena G. Krzystolik, M.D.

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: July 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

US (1)