Vitreomacular Adhesion Including Macular Hole Clinical Trial
— OASISOfficial title:
A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
| Verified date | January 2016 |
| Source | ThromboGenics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects 18 years of age or older and of either gender - Presence of vitreomacular adhesion - Best corrected visual acuity (BCVA) of 20/32 or worse in study eye - BCVA of 20/800 or better in the non-study eye Exclusion Criteria: - History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye - Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye - Macular hole of > 400 µm diameter in the study eye - Presence of epiretinal membrane (ERM) - Aphakia in the study eye - High myopia (more than 8D) in study eye - History of rhegmatogenous retinal detachment in either eye - History of vitrectomy in the study eye - Previous participation in this trial or prior administration of ocriplasmin in the study eye |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Retina Associates | Arlington | Texas |
| United States | Retina Research Center | Austin | Texas |
| United States | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
| United States | Southeast Clinical Research, PA | Charlotte | North Carolina |
| United States | Cincinnati Eye Institute | Cincinnati | Ohio |
| United States | Retina Associates of Cleveland | Cleveland | Ohio |
| United States | Texas Retina Associates | Dallas | Texas |
| United States | Retina Consultants, PA | Fort Worth | Texas |
| United States | Vitroretinal Consultants | Houston | Texas |
| United States | Mid Atlantic Retina | Huntingdon Valley | Pennsylvania |
| United States | Sabates Eye Center Research | Kansas City | Missouri |
| United States | Valley Retina Institute, P.A. | McAllen | Texas |
| United States | MedEye Associates | Miami | Florida |
| United States | Retina-Vitreous Center, PA | New Brunswick | New Jersey |
| United States | Retinal Consultants of Arizona | Phoenix | Arizona |
| United States | Eyesite Opthalmic Services, PA | Portsmouth | New Hampshire |
| United States | Associated Retinal Consultants | Royal Oak | Michigan |
| United States | Retina Consultants Medical Group | Sacramento | California |
| United States | Retina Consultants of San Antonio | San Antonio | Texas |
| United States | West Coast Retina Group, Inc | San Francisco | California |
| United States | Retina Vitrous Surgeons of CNY | Syracuse | New York |
| United States | Retina Association of NJ | Teaneck | New Jersey |
| United States | Eye Care Associate | Tyler | Texas |
| United States | Bay Area Retina Associates | Walnut Creek | California |
| United States | Center for Retina and Macular Disease | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| ThromboGenics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at 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. | Day 28 | No |
| Secondary | Proportion of Subjects With a =2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 | =2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method. | Month 24 | No |