Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
- Conditions
- Vitreomacular Adhesion Including Macular Hole
- Interventions
- Other: Sham injection
- Registration Number
- NCT01429441
- Lead Sponsor
- ThromboGenics
- Brief Summary
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
- Detailed Description
The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham injection Sham injection - Ocriplasmin Ocriplasmin -
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28 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.
- Secondary Outcome Measures
Name Time Method Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24 Month 24 ≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.
Trial Locations
- Locations (24)
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retina Associates of Cleveland
🇺🇸Cleveland, Ohio, United States
Vitroretinal Consultants
🇺🇸Houston, Texas, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Retina Association of NJ
🇺🇸Teaneck, New Jersey, United States
Sabates Eye Center Research
🇺🇸Kansas City, Missouri, United States
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Retina Consultants Medical Group
🇺🇸Sacramento, California, United States
West Coast Retina Group, Inc
🇺🇸San Francisco, California, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
MedEye Associates
🇺🇸Miami, Florida, United States
Retina Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Associated Retinal Consultants
🇺🇸Royal Oak, Michigan, United States
Retina-Vitreous Center, PA
🇺🇸New Brunswick, New Jersey, United States
Southeast Clinical Research, PA
🇺🇸Charlotte, North Carolina, United States
Eyesite Opthalmic Services, PA
🇺🇸Portsmouth, New Hampshire, United States
Retina Vitrous Surgeons of CNY
🇺🇸Syracuse, New York, United States
Retina Consultants, PA
🇺🇸Fort Worth, Texas, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Mid Atlantic Retina
🇺🇸Huntingdon Valley, Pennsylvania, United States
Valley Retina Institute, P.A.
🇺🇸McAllen, Texas, United States
Eye Care Associate
🇺🇸Tyler, Texas, United States