Trial Outcomes & Findings for Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II) (NCT NCT00668785)
NCT ID: NCT00668785
Last Updated: 2019-03-05
Results Overview
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.
TERMINATED
PHASE2
6 participants
March 2010
2019-03-05
Participant Flow
Participant milestones
| Measure |
Ranibizumab
Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Baseline characteristics by cohort
| Measure |
Ranibizumab
n=6 Participants
Ranibizumab is being used off-label to test the safety and efficacy of its use in Diabetic Macular Edema post panretinal photocoagulation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: March 2010Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: March 2010Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: March 2010Population: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Ranibizumab
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
J. Michael Jumper, MD
West Coast Retina Medical Group, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place