Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Phase 3

Completed

Conditions: Vitreomacular Traction

Interventions: Device: Pneumatic Vitreolysis (C3F8 injection)
Other: Observation

Registration Number: NCT03647267

Lead Sponsor: Jaeb Center for Health Research

Brief Summary: Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.

Detailed Description: Investigational Device: 0.3-mL intraocular gas (C3F8) injection

Objectives

Primary

1. To compare the proportion of eyes with central VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole.

Secondary

2. To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection.

Study Design: Multi-center, randomized clinical trial

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

Inclusion Criteria

At least one eye meets the study eye criteria listed below.
Able and willing to provide informed consent.
Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks).
For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks).
Able and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eye

Exclusion

A potential participant is not eligible if any of the following exclusion criteria are present:
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that might preclude completion of follow-up)
Participation in an investigational trial within 30 days of randomization that involves treatment with any drug or device that has not received regulatory approval for the indication being studied at the time of study entry

• Note: study participants should not receive another investigational drug/device while participating in the study
Known contraindication to any component of the treatment
Known allergy to any drug used in the procedure prep (including povidone iodine)
Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months following randomization
Anticipated surgery requiring anesthesia within the next 6 months following randomization

• Participants cannot receive nitrous oxide until gas resolution
For women of child-bearing potential, pregnant at the time of enrollment

• Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgement may be used to determine when a pregnancy test is needed.

Study Eye Criteria

The participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.

A participant can have only one study eye. If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and participant before randomization.

The eligibility criteria for a study eye are as follows:

Inclusion
1. Vitreomacular adhesion on OCT that is no larger than 3000 microns with visible separation of the vitreous on either side as seen on horizontal and vertical scans, confirmed by central reading center Note: presence of epiretinal membrane is neither a requirement nor exclusion.
2. Decreased visual function (e.g. metamorphopsia or other visual symptom) that is attributed to VMT.
Examples of visual symptoms include:

a) Distortion and/or reduction in visual acuity b) Recognized difficulty with reading, driving, or using a computer c) Patient recognized interference with quality of life because of a and/or b.

c. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 78 (20/32 or worse) d. Investigator and participant willing to wait 6 months before surgical intervention, provided visual acuity remains stable

• An eye that requires prompt treatment for VMT should not be enrolled

Exclusion e. Other ocular condition that might affect visual acuity during the course of the study or require intraocular treatment (e.g., retinal vein occlusion, substantial age-related macular degeneration, or macular edema induced by a condition other than VMT) • If diabetic retinopathy is present, severity level must be microaneurysms only or better (≤ diabetic retinopathy severity level 20)

• Presence of drusen is acceptable; however, eyes with geographic atrophy or neovascular age-related macular degeneration involving the macula are excluded f. High level of myopia (spherical equivalent of -8.00 diopters or more myopic if phakic or retinal abnormalities consistent with pathologic myopia if phakic or pseudophakic) g. History of prior gas injection, ocriplasmin injection, or intraocular injection for any reason h. History of prior vitrectomy i. History of uncontrolled glaucoma

• IOP must be <30 mmHg, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible j. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery anticipated within the next 6 months following randomization k. History of YAG capsulotomy performed within 4 months prior to randomization l. Aphakia or anterior chamber intraocular lens m. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis n. Uveitis o. Presence of any macular hole or lamellar hole (according to reading center grading) p. Retinal history or pathology that might predispose an eye to an increased risk of retinal detachment from the procedure

• Untreated retinal tears, not retinal holes, are an exclusion. It is up to the investigator to determine whether extent of lattice degeneration or other pathology might increase the risk of retinal detachment.

q. Any contraindication to paracentesis (e.g., history of narrow angle glaucoma) r. Lenticular or zonular instability

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumatic Vitreolysis	Pneumatic Vitreolysis (C3F8 injection)	Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.
Observation	Observation	Participants randomized to the observation group will receive a sham injection.

Primary Outcome Measures

Name	Time	Method
Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy	at 24 Weeks

Secondary Outcome Measures

Name	Time	Method
Number of Eyes With Rescue Treatment Before the 24-week Visit	up to 24 weeks
Number of Eyes With Central Vitreomacular Traction Status	up to 24 weeks
Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit	through 24 Weeks	scheduled rescue vitrectomy must be completed within the subsequent 12 weeks.
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline	Baseline to 24 weeks	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.

Trial Locations

Locations (41): Elman Retina Group, PA
🇺🇸
Baltimore, Maryland, United States
Illinois Retina Associates, S.C.
🇺🇸
Oak Park, Illinois, United States
Southeast Retina Center, PC
🇺🇸
Augusta, Georgia, United States
Valley Eye Physicians and Surgeons
🇺🇸
Ayer, Massachusetts, United States
Retinal Diagnostic Center
🇺🇸
Campbell, California, United States
Southern California Desert Retina Consultants, MC
🇺🇸
Palm Desert, California, United States
Retina Specialists of Michigan
🇺🇸
Grand Rapids, Michigan, United States
Austin Retina Associates
🇺🇸
Austin, Texas, United States
Florida Retina Consultants
🇺🇸
Lakeland, Florida, United States
MaculaCare
🇺🇸
New York, New York, United States
Northern California Retina Vitreous Associates
🇺🇸
Mountain View, California, United States
East Bay Retina Consultants, Inc
🇺🇸
Oakland, California, United States
Sarasota Retina Institute
🇺🇸
Sarasota, Florida, United States
Southeast Eye Institute, PA dba Eye Associates of Pinellas
🇺🇸
Pinellas Park, Florida, United States
Thomas Eye Group
🇺🇸
Sandy Springs, Georgia, United States
Gailey Eye Clinic
🇺🇸
Bloomington, Illinois, United States
Spokane Eye Clinic
🇺🇸
Spokane, Washington, United States
Paducah Retinal Center
🇺🇸
Paducah, Kentucky, United States
University of Illinois at Chicago Medical Center
🇺🇸
Chicago, Illinois, United States
Western Carolina Clinical Research, LLC
🇺🇸
Asheville, North Carolina, United States
Retina Associates of Cleveland, Inc
🇺🇸
Beachwood, Ohio, United States
Wolfe Eye Clinic
🇺🇸
West Des Moines, Iowa, United States
Oregon Retina, LLP
🇺🇸
Eugene, Oregon, United States
The Retina Institute
🇺🇸
Saint Louis, Missouri, United States
Joslin Diabetes Center
🇺🇸
Boston, Massachusetts, United States
Raj K. Maturi, M.D., P.C.
🇺🇸
Indianapolis, Indiana, United States
Retinal Consultants of San Antonio
🇺🇸
San Antonio, Texas, United States
Atlantis Eye Care
🇺🇸
Huntington Beach, California, United States
National Ophthalmic Research Institute
🇺🇸
Fort Myers, Florida, United States
University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr
🇺🇸
Jacksonville, Florida, United States
Mid-America Retina Consultants, P.A.
🇺🇸
Overland Park, Kansas, United States
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
🇺🇸
West Monroe, Louisiana, United States
Vitreo-Retinal Associates, PC
🇺🇸
Worcester, Massachusetts, United States
Charlotte Eye, Ear, Nose, and Throat Assoc., PA
🇺🇸
Charlotte, North Carolina, United States
Retina Vitreous Center
🇺🇸
Edmond, Oklahoma, United States
Retina Research Center
🇺🇸
Austin, Texas, United States
Southeastern Retina Associates
🇺🇸
Chattanooga, Tennessee, United States
Southeastern Retina Associates, PC
🇺🇸
Knoxville, Tennessee, United States
Mayo Clinic Department of Opthalmology
🇺🇸
Rochester, Minnesota, United States
Retina Northwest, PC
🇺🇸
Portland, Oregon, United States
Florida Retina Institute
🇺🇸
Orlando, Florida, United States