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Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

Primary Purpose

Proliferative Diabetic Retinopathy, Macular Edema

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Jumper, J. Michael, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Ranibizumab, Proliferative Diabetic Retinopathy, Macular Edema following Panretinal Photocoagulation, Safety and Efficacy, Intravitreal Injection

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography AND 7-14 day post-PRP OCT
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age 21 years or older
  • Previously untreated PDR patients with high risk characteristics who develop edema within 7-14 days post PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>10% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>10% increase from pre-PRP macular volume).

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) prior to enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Participation in another simultaneous medical investigation or trial
  • Pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP
  • Neovascularization of the iris or neovascular glaucoma
  • Increased central foveal thickness for any other reason
  • Concurrent macular diseases that could confound the results of this study
  • Prior vitrectomy in the study eye
  • Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide

Sites / Locations

  • West Coast Retina Medical Group Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.

Outcomes

Primary Outcome Measures

Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.)
No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.

Secondary Outcome Measures

Mean Change From Pre-PRP Optical Coherence Tomography (OCT) in Central Foveal Thickness and Macular Volume as Assessed by OCT at 1, 2 and 3 Months.
No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.
Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point
No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.

Full Information

First Posted
April 25, 2008
Last Updated
February 13, 2019
Sponsor
Jumper, J. Michael, M.D.
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00668785
Brief Title
Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Official Title
Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to low enrollment
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jumper, J. Michael, M.D.
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, open-label Phase II study evaluating the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.
Detailed Description
Levels of VEGF are elevated in eyes wth Diabetic Macular Edema and the expression of VEGF was found to be elevated temporarily following the photocoagulation of human Retinal Pigment Epithelial (RPE) cells. Ranibizumab (Lucentis TM, Genentech) is an anti-VEGF antibody shown to have properties to prevent macular edema. We hypothesize that VEGF inhibition can effectively treat PRP-induced macular edema, thereby minimizing post-PRP vision loss. Subjects who meet eligibility criteria will receive 0.5mg ranibizumab administered 7-14 days post-PRP. Additional intravitreal injections of 0.5 mg of ranibizumab at Day 30 and/or Day 60 may be also be administered. All subjects will be followed for 90 days for safety and efficacy assessments. There is no placebo or sham arm of this trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Macular Edema
Keywords
Ranibizumab, Proliferative Diabetic Retinopathy, Macular Edema following Panretinal Photocoagulation, Safety and Efficacy, Intravitreal Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.
Primary Outcome Measure Information:
Title
Mean Change From Pre-PRP Best Corrected Visual Acuity (BCVA) at 3 Months as Expressed as an Early Treatment Diabetic Retinopathy Study (ETDRS) Score (Number of Letters Correctly Read.)
Description
No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.
Time Frame
March 2010
Secondary Outcome Measure Information:
Title
Mean Change From Pre-PRP Optical Coherence Tomography (OCT) in Central Foveal Thickness and Macular Volume as Assessed by OCT at 1, 2 and 3 Months.
Description
No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.
Time Frame
March 2010
Title
Percentage of Patients That Maintain Pre-PRP Visual Acuity at the 3 Month Time Point
Description
No outcome measures were obtained for this study. Study was terminated by Investigator/Sponsor due to low enrollment. The data was not formally analyzed but reviewed only on a case study basis.
Time Frame
March 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography AND 7-14 day post-PRP OCT Ability to provide written informed consent and comply with study assessments for the full duration of the study Age 21 years or older Previously untreated PDR patients with high risk characteristics who develop edema within 7-14 days post PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>10% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>10% increase from pre-PRP macular volume). Exclusion Criteria: Pregnancy (positive pregnancy test) prior to enrollment in the study Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. Participation in another simultaneous medical investigation or trial Pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP Neovascularization of the iris or neovascular glaucoma Increased central foveal thickness for any other reason Concurrent macular diseases that could confound the results of this study Prior vitrectomy in the study eye Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Michael Jumper, M.D.
Organizational Affiliation
West Coast Retina Medical Group, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Coast Retina Medical Group Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

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