Effects of Pneumatic Vitreolysis on Vitreomacular Traction

NCT ID: NCT03647267

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2020-08-06

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

Conditions

Vitreomacular Traction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pneumatic Vitreolysis

Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.

Group Type: ACTIVE_COMPARATOR

Pneumatic Vitreolysis (C3F8 injection)

Intervention Type: DEVICE

Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.

Observation

Participants randomized to the observation group will receive a sham injection.

Group Type: PLACEBO_COMPARATOR

Observation

Intervention Type: OTHER

No intervention; sham injection only

Interventions

Pneumatic Vitreolysis (C3F8 injection)

Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.

Intervention Type: DEVICE

Observation

No intervention; sham injection only

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. At least one eye meets the study eye criteria listed below.

2. Able and willing to provide informed consent.

3. Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks).

4. For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks).

5. Able and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eye

Exclusion

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

6. 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)

7. 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

8. Known contraindication to any component of the treatment

9. Known allergy to any drug used in the procedure prep (including povidone iodine)

10. 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

11. Anticipated surgery requiring anesthesia within the next 6 months following randomization

• Participants cannot receive nitrous oxide until gas resolution

12. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clement Chan, MD

Role: STUDY_CHAIR

Southern California Desert Retina Consultants, MC

Locations

Retinal Diagnostic Center

Campbell, California, United States

Atlantis Eye Care

Huntington Beach, California, United States

Northern California Retina Vitreous Associates

Mountain View, California, United States

East Bay Retina Consultants, Inc

Oakland, California, United States

Southern California Desert Retina Consultants, MC

Palm Desert, 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

Florida Retina Consultants

Lakeland, Florida, United States

Florida Retina Institute

Orlando, Florida, United States

Southeast Eye Institute, PA dba Eye Associates of Pinellas

Pinellas Park, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

Southeast Retina Center, PC

Augusta, Georgia, United States

Thomas Eye Group

Sandy Springs, Georgia, United States

Gailey Eye Clinic

Bloomington, Illinois, United States

University of Illinois at Chicago Medical Center

Chicago, Illinois, United States

Illinois Retina Associates, S.C.

Oak Park, Illinois, United States

Raj K. Maturi, M.D., P.C.

Indianapolis, Indiana, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Mid-America Retina Consultants, P.A.

Overland Park, Kansas, United States

Paducah Retinal Center

Paducah, Kentucky, United States

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

West Monroe, Louisiana, United States

Elman Retina Group, PA

Baltimore, Maryland, United States

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, United States

Retina Specialists of Michigan

Grand Rapids, Michigan, United States

Mayo Clinic Department of Opthalmology

Rochester, Minnesota, United States

The Retina Institute

St Louis, Missouri, United States

MaculaCare

New York, New York, United States

Western Carolina Clinical Research, LLC

Asheville, North Carolina, United States

Charlotte Eye, Ear, Nose, and Throat Assoc., PA

Charlotte, North Carolina, United States

Retina Associates of Cleveland, Inc

Beachwood, Ohio, United States

Retina Vitreous Center

Edmond, Oklahoma, United States

Oregon Retina, LLP

Eugene, Oregon, United States

Retina Northwest, PC

Portland, Oregon, United States

Southeastern Retina Associates

Chattanooga, Tennessee, United States

Southeastern Retina Associates, PC

Knoxville, Tennessee, United States

Austin Retina Associates

Austin, Texas, United States

Retina Research Center

Austin, Texas, United States

Retinal Consultants of San Antonio

San Antonio, Texas, United States

Spokane Eye Clinic

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U10EY014231

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10EY023207

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DRCR.net Protocol AG

Identifier Type: -

Identifier Source: org_study_id