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CompletedNCT01889251Updated Nov 30, 2015Results posted

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

A Phase 3 interventional study of Ocriplasmin and Sham injection in Symptomatic Vitreomacular Adhesion, sponsored by Alcon Research. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-11-30.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
251
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Symptomatic Vitreomacular Adhesion

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Keywords

  • 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
03

In context

Tissue Adhesions

241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's enrollment of 251 is above the median of 60 across 184 interventional studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
251 participants (actual)

Study arms

  • Experimental
    Ocriplasmin

    Ocriplasmin administered as a single intravitreal injection to the study eye at baseline

    Drug: Ocriplasmin

  • Sham comparator
    Sham injection

    Single sham injection to the study eye at baseline

    Drug: Sham injection

Interventions

  • DrugOcriplasmin

    Also known as: A01016

  • DrugSham injection
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 28

07

Results

Posted Oct 29, 2015

Participant flow

Subjects were recruited from 40 study centers located in Japan.

Participant flow — Overall Study
MilestoneOcriplasminSham Injection
Started11557
Completed11457
Not completed10
Withdrew: Adverse event10

Outcome measures

PrimaryProportion 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.

Time frame:
Day 28
Reported as:
Number · percentage of subjects
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
percentage of subjectsOcriplasminSham Injection
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)52.21.8

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ocriplasmin—23/114 (20.2%)63/114 (55.3%)
Sham Injection—4/58 (6.9%)19/58 (32.8%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventOcriplasminSham Injection
Macular holeEye disorders11/1143/58
Retinal detachmentEye disorders3/1140/58
Vitreous adhesionsEye disorders2/1141/58
PneumoniaInfections and infestations2/1140/58
Cervix carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1140/58
Spinal compression fractureInjury, poisoning and procedural complications1/1140/58
AsthmaRespiratory, thoracic and mediastinal disorders1/1140/58
Ocular hypertensionEye disorders1/1140/58
Angle closure glaucomaEye disorders1/1140/58
Intraocular pressure increasedInvestigations1/1140/58
Most frequent other events
Showing 10 of 12
Most frequent other events
EventOcriplasminSham Injection
Conjunctival haemorrhageEye disorders22/1145/58
Vitreous floatersEye disorders14/1142/58
Anterior chamber cellEye disorders13/1143/58
Eye painEye disorders13/1141/58
Back painMusculoskeletal and connective tissue disorders11/1144/58
Conjunctival hyperaemiaEye disorders9/1140/58
Visual impairmentEye disorders8/1141/58
Corneal disorderEye disorders8/1140/58
Intraocular pressure increasedInvestigations7/1144/58
ConstipationGastrointestinal disorders2/1144/58

Baseline characteristics

This analysis population includes all randomized subjects, as randomized.

Age, Continuous
Age, Continuous(years)OcriplasminSham InjectionTotal
Mean68.1 ± 7.368.6 ± 9.268.2 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)OcriplasminSham InjectionTotal
Female593291
Male562581
08

Study locations

1 site
  • Contact Alcon for Trial Locations
    Tokyo, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01889251
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jun 28, 2013
Start date
Jul 2013
Primary completion
Sep 2014
Completion
Sep 2014
Results posted
Oct 29, 2015
Last update
Nov 30, 2015

Study contacts

Group Manager, Clinical Development
study director · Alcon Japan, Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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