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Study was terminated due to low enrollment
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | March 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | March 2010 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Michael Jumper, M.D. | West Coast Retina Medical Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Retina Medical Group Inc. | San Francisco | California | 94107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 6 subjects were enrolled in the study: 2 in the observation arm and 4 in the treatment arm. There were only 4 visits in the schedule of assessments and 3 of the subjects missed 2 visits or more. Due to the lack of data collected, the mean change in visual acuity could not be accurately analyzed and calculated. | Posted | March 2010 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranibizumab | Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. |
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Study was terminated by Sponsor and Investigator due to low enrollment. Data not analyzed. Technical problems with measurement leading to unreliable or uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Michael Jumper, MD | West Coast Retina Medical Group, Inc. | 415-972-4600 | jmjumper@westcoastretina.com |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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. | March 2010 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | 6 subjects were enrolled in the study: 2 in the observation arm and 4 in the treatment arm. There were only 4 visits in the schedule of assessments and 3 of the subjects missed 2 visits or more. Due to the lack of data collected, the mean change in central foveal thickness could not be accurately analyzed and calculated. | Posted | March 2010 |
|
|
| Secondary | 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. | 6 subjects were enrolled in the study: 2 in the observation arm and 4 in the treatment arm. There were only 4 visits in the schedule of assessments and 3 of the subjects missed 2 visits or more. Due to the lack of data collected, the percentage of patients that maintain pre-PRP visual acuity could not be accurately analyzed and calculated. | Posted | March 2010 |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |