Macular Edema, Proliferative Diabetic Retinopathy
Conditions
Keywords
Ranibizumab, Proliferative Diabetic Retinopathy, Macular Edema following Panretinal Photocoagulation, Safety and Efficacy, Intravitreal Injection
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.
Interventions
DRUGranibizumab
Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.
Sponsors
Genentech, Inc.
Jumper, J. Michael, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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.) | March 2010 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | March 2010 | 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 | March 2010 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Ranibizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: March 2010
Population: 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.
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.
Time frame: March 2010
Population: 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.
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.
Time frame: March 2010
Population: 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.