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

Symptomatic Vitreomacular Adhesion Clinical Trial

Official title:

A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889251
• Other study ID #: J-12-075
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2013
• Last updated: November 2, 2015
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Symptomatic Vitreomacular Adhesion
• Tissue Adhesions

Intervention

Drug:
• Ocriplasmin

• Sham injection

Locations

Country	Name	City	State
Japan	Contact Alcon for Trial Locations	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No