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

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ClinicalTrials.gov Identifier: NCT01889251
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : October 29, 2015
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE June 26, 2013
First Posted Date  ICMJE June 28, 2013
Results First Submitted Date  ICMJE September 30, 2015
Results First Posted Date  ICMJE October 29, 2015
Last Update Posted Date November 30, 2015
Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) [ Time Frame: Day 28 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Proportion of Subjects with Non-Surgical Resolution of Vitreomacular Adhesion [ Time Frame: Day 28 ]
As determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Official Title  ICMJE A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Vitreomacular Adhesion
Intervention  ICMJE
  • Drug: Ocriplasmin
    Other Name: A01016
  • Drug: Sham injection
Study Arms  ICMJE
  • Experimental: Ocriplasmin
    Ocriplasmin administered as a single intravitreal injection to the study eye at baseline
    Intervention: Drug: Ocriplasmin
  • Sham Comparator: Sham injection
    Single sham injection to the study eye at baseline
    Intervention: Drug: Sham injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2015)
251
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
168
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889251
Other Study ID Numbers  ICMJE J-12-075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Group Manager, Clinical Development Alcon Japan, Ltd.
PRS Account Alcon Research
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP