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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01889251
First received: June 26, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Vitreomacular Adhesion
Drug: A01016
Drug: Sham injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Proportion of Subjects with Non-Surgical Resolution of Vitreomacular Adhesion [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    As determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT)


Estimated Enrollment: 168
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A01016
A01016 administered as a single intravitreal injection to the study eye at baseline
Drug: A01016
Sham Comparator: Sham injection
Single sham injection to the study eye at baseline
Drug: Sham injection

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01889251

Locations
Japan
Contact Alcon for Trial Locations
Tokyo, Japan
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Atsushi Morishima Alcon Japan, Ltd.
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01889251     History of Changes
Other Study ID Numbers: J-12-075
Study First Received: June 26, 2013
Last Updated: March 28, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Alcon Research:
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

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014