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

NCT ID: NCT00841373

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Retinal Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Panretinal Photocoagulation

Group Type ACTIVE_COMPARATOR

Panretinal Photocoagulation

Intervention Type PROCEDURE

Panretinal Photocoagulation treatment

2

Ranibizumab Supplementing Panretinal Laser Photocoagulation

Group Type ACTIVE_COMPARATOR

Panretinal Photocoagulation and intravitreal injection of ranibizumab

Intervention Type PROCEDURE

Panretinal photocoagulation and ranibizumab

Interventions

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Panretinal Photocoagulation

Panretinal Photocoagulation treatment

Intervention Type PROCEDURE

Panretinal Photocoagulation and intravitreal injection of ranibizumab

Panretinal photocoagulation and ranibizumab

Intervention Type PROCEDURE

Other Intervention Names

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laser and Lucentis

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Southern New England Retina Associates

OTHER

Sponsor Role lead

Responsible Party

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Mary Savell

Madgalena G. Krzystolik, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena G Krzystolik, MD

Role: PRINCIPAL_INVESTIGATOR

Southern New England Retina Associates

Locations

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Southern New England Retina Associates

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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100,611

Identifier Type: -

Identifier Source: org_study_id