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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Mary Savell, Southern New England Retina Associates
ClinicalTrials.gov Identifier:
NCT00841373
First received: February 10, 2009
Last updated: November 17, 2014
Last verified: November 2014

February 10, 2009
November 17, 2014
July 2007
January 2009   (final data collection date for primary outcome measure)
  • The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam. [ Time Frame: 1 to 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00841373 on ClinicalTrials.gov Archive Site
  • The mean change in best corrected visual acuity score [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • The percentage/number of patients that experience vision loss of 30 letters or less [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • The percentage number of patients that experience vision improvement of more than 15 letters [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • The percentage/number of patients whose vision progressed to no light perception [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • The mean change in macular thickness on OCT [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
  • The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure [ Time Frame: 1 to 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ranibizumab Supplementing Panretinal Photocoagulation as Treatment for Iris/Angle Neovascularization in Retinal Ischemic Disease
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Retinal Ischemia
  • Procedure: Panretinal Photocoagulation
    Panretinal Photocoagulation treatment
  • Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab
    Panretinal photocoagulation and ranibizumab
    Other Name: laser and Lucentis
  • Active Comparator: 1
    Panretinal Photocoagulation
    Intervention: Procedure: Panretinal Photocoagulation
  • Active Comparator: 2
    Ranibizumab Supplementing Panretinal Laser Photocoagulation
    Intervention: Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
January 2010
January 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00841373
100,611
Yes
Mary Savell, Southern New England Retina Associates
Southern New England Retina Associates
Genentech, Inc.
Principal Investigator: Magdalena G Krzystolik, MD Southern New England Retina Associates
Southern New England Retina Associates
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP