Phase 2
N=100
Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
Exudative Age-Related Macular Degeneration · Focal Vitreomacular Adhesion
Bottom Line
View on ClinicalTrials.gov: NCT00913744 ↗Enrolled (actual)
100
Serious AEs
20.0%
Results posted
May 2014
Primary outcome: Primary: Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 — 24.3; 12.0 percentage of subjects — p=0.262
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ocriplasmin (Drug); Sham injection (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- ThromboGenics
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 |
24.3; 12.0 | 0.262 |
Summary
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).
Eligibility Criteria
Inclusion Criteria
- Male or female subjects aged > 50
- Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
- Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
- The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area
- The total lesion area must be 8D) or aphakia in the study eye
- Subjects who have had ocular surgery in the study eye in the prior three months
- Subjects who have had a vitrectomy in the study eye at any time.
Data sourced from ClinicalTrials.gov (NCT00913744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.