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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014