A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion

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Alcon

Status and phase

Completed
Phase 3

Conditions

Symptomatic Vitreomacular Adhesion

Treatments

Drug: Ocriplasmin
Drug: Sham injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01889251
J-12-075

Details and patient eligibility

About

The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.

Enrollment

251 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
  • Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
  • BCVA of 20/800 or better in the non-study eye;
  • Provide written informed consent;
  • Follow specified instructions during study period;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
  • Vitreous hemorrhage or other opacification;
  • High myopia in the study eye;
  • Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
  • Uncontrolled glaucoma in the study eye;
  • History of retinal detachment in either eye;
  • Active infection in either eye;
  • Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
  • Participation in another investigational drug study within 30 days prior to this study;
  • Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

251 participants in 2 patient groups

Ocriplasmin
Experimental group
Description:
Ocriplasmin administered as a single intravitreal injection to the study eye at baseline
Treatment:
Drug: Ocriplasmin
Sham injection
Sham Comparator group
Description:
Single sham injection to the study eye at baseline
Treatment:
Drug: Sham injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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