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

NCT01889251 | Completed Phase 3 Results

• 1 other identifier: J-12-075
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Vitreomacular Adhesion

Keywords

Vitreomacular Adhesion; Vitreomacular Traction; Vitreomacular Traction Syndrome; Vitrectomy; Central Visual Field Defect; Blind Spot; Intravitreal Injection; Macula; Retina; Decreased Visual Acuity; Visual Complaint; SD-OCT; Macular Hole

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)

  VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.

  Day 28

Study Arms (2)

Ocriplasmin

EXPERIMENTAL

Ocriplasmin administered as a single intravitreal injection to the study eye at baseline

Drug: Ocriplasmin

Sham injection

SHAM COMPARATOR

Single sham injection to the study eye at baseline

Drug: Sham injection

Interventions

Ocriplasmin DRUG

Also known as: A01016

Ocriplasmin

Sham injection DRUG

Sham injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon for Trial Locations

Tokyo, Japan

Location

MeSH Terms

Conditions

Scotoma; Retinal Perforations

Interventions

microplasmin; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Diseases

Results Point of Contact

• Title: Group Manager, Clinical Development
• Organization: Alcon Japan, Ltd.

+81368995277

Study Officials

• Group Manager, Clinical Development

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 30, 2015
• Results First Posted: October 29, 2015

Record last verified: 2015-11

Locations

JP (1)