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

Primary Purpose

Retinal Ischemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Panretinal Photocoagulation

Panretinal Photocoagulation and intravitreal injection of ranibizumab

About this trial

This is an interventional treatment trial for Retinal Ischemia focused on measuring Retinal ischemia: Iris/Angle Neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Southern New England Retina Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Panretinal Photocoagulation

Ranibizumab Supplementing Panretinal Laser Photocoagulation

Outcomes

Primary Outcome Measures

The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam.

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.

Secondary Outcome Measures

The mean change in best corrected visual acuity score

The percentage/number of patients that experience vision loss of 30 letters or less

The percentage number of patients that experience vision improvement of more than 15 letters

The percentage/number of patients whose vision progressed to no light perception

The mean change in macular thickness on OCT

The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision

The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure

Full Information

NCT ID

NCT00841373

First Posted

February 10, 2009

Last Updated

November 17, 2014

Sponsor

Southern New England Retina Associates

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00841373

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southern New England Retina Associates

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Ischemia

Keywords

Retinal ischemia: Iris/Angle Neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Panretinal Photocoagulation

Arm Title

Arm Type

Active Comparator

Arm Description

Ranibizumab Supplementing Panretinal Laser Photocoagulation

Intervention Type

Procedure

Intervention Name(s)

Panretinal Photocoagulation

Intervention Description

Panretinal Photocoagulation treatment

Intervention Type

Procedure

Intervention Name(s)

Panretinal Photocoagulation and intravitreal injection of ranibizumab

Other Intervention Name(s)

laser and Lucentis

Intervention Description

Panretinal photocoagulation and ranibizumab

Primary Outcome Measure Information:

Title

The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam.

Time Frame

1 to 12 months

Title

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.

Time Frame

1 to 12 months

Secondary Outcome Measure Information:

Title

The mean change in best corrected visual acuity score

Time Frame

1 to 12 months

Title

The percentage/number of patients that experience vision loss of 30 letters or less

Time Frame

1 to 12 months

Title

The percentage number of patients that experience vision improvement of more than 15 letters

Time Frame

1 to 12 months

Title

The percentage/number of patients whose vision progressed to no light perception

Time Frame

1 to 12 months

Title

The mean change in macular thickness on OCT

Time Frame

1 to 12 months

Title

The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision

Time Frame

1 to 12 months

Title

The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure

Time Frame

1 to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magdalena G Krzystolik, MD

Organizational Affiliation

Southern New England Retina Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Southern New England Retina Associates

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02904

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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