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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Southern New England Retina Associates.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by:
Southern New England Retina Associates
ClinicalTrials.gov Identifier:
NCT00841373
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Retinal Ischemia
 Procedure: Panretinal Photocoagulation
Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ranibizumab Supplementing Panretinal Photocoagulation as Treatment for Iris/Angle Neovascularization in Retinal Ischemic Disease

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Southern New England Retina Associates:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: July 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Panretinal Photocoagulation
 Procedure: Panretinal Photocoagulation
Panretinal Photocoagulation treatment
Active Comparator: 2
Ranibizumab Supplementing Panretinal Laser Photocoagulation
 Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab
Panretinal photocoagulation and ranibizumab
Other Name: laser and Lucentis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841373

Contacts
Contact: Magdalena G Krzystolik, MD 401-453-4600 Magdalena_Krzystolik@brown.edu
Contact: Mary B Savell, RNBSN

Locations
United States, Rhode Island
Southern New England Retina Associates Recruiting
Providence, Rhode Island, United States, 02904
Contact: Magdalena G Krzystolik, MD     401-453-4600        
Contact: Mary B Savell, RNBSN     401-4563-4600     marysavell@cox.net    
Principal Investigator: Magdalena G Krzystolik, MD            
Sponsors and Collaborators
Southern New England Retina Associates
Genentech
Investigators
Principal Investigator: Magdalena G Krzystolik, MD Southern New England Retina Associates
  More Information

No publications provided

Responsible Party: Magdalena G. Krzystolik M.D., Southern New England Retina Associates
ClinicalTrials.gov Identifier: NCT00841373     History of Changes
Other Study ID Numbers: 100,611
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Southern New England Retina Associates:
Retinal ischemia: Iris/Angle Neovascularization

Additional relevant MeSH terms:
Ischemia
Neovascularization, Pathologic
Pathologic Processes
Metaplasia

ClinicalTrials.gov processed this record on May 16, 2013