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Completed

NCT Number: NCT00841373

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

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.

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Key information

Conditions

Retinal Ischemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Southern New England Retina Associates

Providence, Rhode Island, 02904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Panretinal Photocoagulation

Procedure

Panretinal Photocoagulation treatment

Panretinal Photocoagulation and intravitreal injection of ranibizumab

Procedure

Panretinal photocoagulation and ranibizumab

Other names: laser and Lucentis

Primary outcomes

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

    Time frame: 1 to 12 months

  2. 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 outcomes

  1. The mean change in best corrected visual acuity score

    Time frame: 1 to 12 months

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

    Time frame: 1 to 12 months

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

    Time frame: 1 to 12 months

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

    Time frame: 1 to 12 months

  5. The mean change in macular thickness on OCT

    Time frame: 1 to 12 months

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

    Time frame: 1 to 12 months

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

    Time frame: 1 to 12 months

Sponsors and collaborators

Lead sponsor

Southern New England Retina Associates

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Feb 11, 2009
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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