Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Symptomatic Vitreomacular Adhesion
Interventions Drug: Ocriplasmin
Drug: Sham injection
Enrollment 251
Recruitment Details Subjects were recruited from 40 study centers located in Japan.
Pre-assignment Details Of the 251 enrolled, 79 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (172).
Arm/Group Title Ocriplasmin Sham Injection
Hide Arm/Group Description Single intravitreal injection to the study eye at baseline Single sham injection to the study eye at baseline
Period Title: Overall Study
Started 115 57
Completed 114 57
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Ocriplasmin Sham Injection Total
Hide Arm/Group Description Single intravitreal injection to the study eye at baseline Single sham injection to the study eye at baseline Total of all reporting groups
Overall Number of Baseline Participants 115 57 172
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects, as randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants 57 participants 172 participants
68.1  (7.3) 68.6  (9.2) 68.2  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants 57 participants 172 participants
Female
59
  51.3%
32
  56.1%
91
  52.9%
Male
56
  48.7%
25
  43.9%
81
  47.1%
1.Primary Outcome
Title Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
Hide Description 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.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.
Arm/Group Title Ocriplasmin Sham Injection
Hide Arm/Group Description:
Single intravitreal injection to the study eye at baseline
Single sham injection to the study eye at baseline
Overall Number of Participants Analyzed 115 57
Measure Type: Number
Unit of Measure: percentage of subjects
52.2 1.8
Time Frame Adverse events (AEs) were collected for the duration of the study (1 year, 2 months). This analysis group includes all subjects who received study medication, as treated. Note: One subject randomized to Ocriplasmin was inadvertently treated with Sham.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Ocular adverse events are presented for both study eye and non-study eye.
 
Arm/Group Title Ocriplasmin Sham Injection
Hide Arm/Group Description Single intravitreal injection to the study eye at baseline Single sham injection to the study eye at baseline
All-Cause Mortality
Ocriplasmin Sham Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ocriplasmin Sham Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   23/114 (20.18%)   4/58 (6.90%) 
Eye disorders     
Macular hole  11/114 (9.65%)  3/58 (5.17%) 
Vitreous adhesions  2/114 (1.75%)  1/58 (1.72%) 
Retinal detachment  3/114 (2.63%)  0/58 (0.00%) 
Ocular hypertension  1/114 (0.88%)  0/58 (0.00%) 
Angle closure glaucoma  1/114 (0.88%)  0/58 (0.00%) 
Macular pseudohole  1/114 (0.88%)  0/58 (0.00%) 
Infections and infestations     
Pneumonia  2/114 (1.75%)  0/58 (0.00%) 
Injury, poisoning and procedural complications     
Spinal compression fracture  1/114 (0.88%)  0/58 (0.00%) 
Investigations     
Intraocular pressure increased  1/114 (0.88%)  0/58 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma  1/114 (0.88%)  0/58 (0.00%) 
Malignant melanoma  1/114 (0.88%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1/114 (0.88%)  0/58 (0.00%) 
1
Term from vocabulary, MedDRA/J (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocriplasmin Sham Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   63/114 (55.26%)   19/58 (32.76%) 
Eye disorders     
Conjunctival haemorrhage  22/114 (19.30%)  5/58 (8.62%) 
Vitreous floaters  14/114 (12.28%)  2/58 (3.45%) 
Anterior chamber cell  13/114 (11.40%)  3/58 (5.17%) 
Eye pain  13/114 (11.40%)  1/58 (1.72%) 
Conjunctival hyperaemia  9/114 (7.89%)  0/58 (0.00%) 
Visual impairment  8/114 (7.02%)  1/58 (1.72%) 
Corneal disorder  8/114 (7.02%)  0/58 (0.00%) 
Punctate keratitis  7/114 (6.14%)  1/58 (1.72%) 
Retinal detachment  7/114 (6.14%)  0/58 (0.00%) 
Gastrointestinal disorders     
Constipation  2/114 (1.75%)  4/58 (6.90%) 
Investigations     
Intraocular pressure increased  7/114 (6.14%)  4/58 (6.90%) 
Musculoskeletal and connective tissue disorders     
Back pain  11/114 (9.65%)  4/58 (6.90%) 
1
Term from vocabulary, MedDRA/J (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Group Manager, Clinical Development
Organization: Alcon Japan, Ltd.
Phone: +81368995277
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01889251    
Other Study ID Numbers: J-12-075
First Submitted: June 26, 2013
First Posted: June 28, 2013
Results First Submitted: September 30, 2015
Results First Posted: October 29, 2015
Last Update Posted: November 30, 2015