Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

Phase 3

Completed

• Conditions: Vitreomacular Adhesion Including Macular Hole
• Interventions: Other: Sham injection; Drug: Ocriplasmin

• 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.

Study Timeline

• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Study Start: 2011-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-10-29
• Results First Submitted QC: 2015-12-02
• Status Verified: 2016-01
• Results First Posted: 2016-01-11
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

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)

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Retina Consultants Medical Group; 🇺🇸 Sacramento, California, United States

West Coast Retina Group, Inc; 🇺🇸 San Francisco, California, United States

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States

MedEye Associates; 🇺🇸 Miami, Florida, United States

Center for Retina and Macular Disease; 🇺🇸 Winter Haven, Florida, United States

Associated Retinal Consultants; 🇺🇸 Royal Oak, Michigan, United States

Sabates Eye Center Research; 🇺🇸 Kansas City, Missouri, United States

Eyesite Opthalmic Services, PA; 🇺🇸 Portsmouth, New Hampshire, United States

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