Clinical trial NCT01429441: Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Official title: A Randomized, Sham-controlled, Double-masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitreomacular Adhesion Including Macular Hole
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.

Detailed description: The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (VMT) including macular hole.

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of age or older and of either gender
* Presence of vitreomacular adhesion
* Best corrected visual acuity (BCVA) of 20/32 or worse in study eye
* BCVA of 20/800 or better in the non-study eye

Exclusion Criteria:

* History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (AMD) or retinal vein occlusion in the study eye
* Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by spectral-domain optical coherence tomography (SD-OCT) in the study eye
* Macular hole of \> 400 µm diameter in the study eye
* Presence of epiretinal membrane (ERM)
* Aphakia in the study eye
* High myopia (more than 8D) in study eye
* History of rhegmatogenous retinal detachment in either eye
* History of vitrectomy in the study eye
* Previous participation in this trial or prior administration of ocriplasmin in the study eye

Primary outcomes:
measure: Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24
timeFrame: Month 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Sacramento
country: United States
facility: Retina Consultants Medical Group
state: California
city: San Francisco
country: United States
facility: West Coast Retina Group, Inc
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Royal Oak
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Kansas City
country: United States
facility: Sabates Eye Center Research
state: Missouri
city: Portsmouth
country: United States
facility: Eyesite Opthalmic Services, PA
state: New Hampshire
city: New Brunswick
country: United States
facility: Retina-Vitreous Center, PA
state: New Jersey
city: Teaneck
country: United States
facility: Retina Association of NJ
state: New Jersey
city: Syracuse
country: United States
facility: Retina Vitrous Surgeons of CNY
state: New York
city: Charlotte
country: United States
facility: Southeast Clinical Research, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Huntingdon Valley
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Fort Worth
country: United States
facility: Retina Consultants, PA
state: Texas
city: Houston
country: United States
facility: Vitroretinal Consultants
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, P.A.
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of San Antonio
state: Texas
city: Tyler
country: United States
facility: Eye Care Associate
state: Texas
Study officials:
References:
citation: Velaga SB, Nittala MG, Ip MS, Duchateau L, Sadda SR. Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial. BMJ Open Ophthalmol. 2021 Jun 21;6(1):e000648. doi: 10.1136/bmjophth-2020-000648. eCollection 2021.
citation: Yu TM, Dugel PU, Haller JA, Kaiser PK, Arnold RJ. Budget impact analysis of ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the USA. J Comp Eff Res. 2018 Dec;7(12):1195-1207. doi: 10.2217/cer-2018-0057. Epub 2018 Oct 23.