Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)
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|ClinicalTrials.gov Identifier: NCT01429441|
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : January 11, 2016
Last Update Posted : March 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vitreomacular Adhesion Including Macular Hole||Drug: Ocriplasmin Other: Sham injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
0.125 mg single intravitreal injection
|Sham Comparator: Sham injection||
Other: Sham injection
- Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 [ Time Frame: Day 28 ]Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.
- Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 [ Time Frame: Month 24 ]≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429441