Effects of Pneumatic Vitreolysis on Vitreomacular Traction

NCT03647267 | Completed Phase 3 Results DMC FDA Device

• 3 other identifiers: DRCR.net Protocol AGU10EY014231U10EY023207
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 41

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.

Conditions

Vitreomacular Traction

Outcome Measures

Primary Outcomes (1)

• Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy

  at 24 Weeks

Secondary Outcomes (4)

• Number of Eyes With Rescue Treatment Before the 24-week Visit

  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

• Number of Eyes With Central Vitreomacular Traction Status

  up to 24 weeks

• Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline

  Baseline to 24 weeks

Study Arms (2)

Pneumatic Vitreolysis

ACTIVE COMPARATOR

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

Device: Pneumatic Vitreolysis (C3F8 injection)

Observation

PLACEBO COMPARATOR

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

Other: Observation

Interventions

Pneumatic Vitreolysis (C3F8 injection) 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.

Pneumatic Vitreolysis

Observation OTHER

No intervention; sham injection only

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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:
• Decreased visual function (e.g. metamorphopsia or other visual symptom) that is attributed to VMT.
• Examples of visual symptoms include:

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator

Study Sites (41)

Retinal Diagnostic Center

Campbell, California, 95008, United States

Location

Atlantis Eye Care

Huntington Beach, California, 92647-8693, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040-4123, United States

Location

East Bay Retina Consultants, Inc

Oakland, California, 94609-3028, United States

Location

Southern California Desert Retina Consultants, MC

Palm Desert, California, 92211, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr

Jacksonville, Florida, 32209, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

Florida Retina Institute

Orlando, Florida, 32806-1101, United States

Location

Southeast Eye Institute, PA dba Eye Associates of Pinellas

Pinellas Park, Florida, 33782-4418, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

Location

Thomas Eye Group

Sandy Springs, Georgia, 30328, United States

Location

Gailey Eye Clinic

Bloomington, Illinois, 61704-2484, United States

Location

University of Illinois at Chicago Medical Center

Chicago, Illinois, 60612, United States

Location

Illinois Retina Associates, S.C.

Oak Park, Illinois, 60304, United States

Location

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

Indianapolis, Indiana, 46290, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266-7705, United States

Location

Mid-America Retina Consultants, P.A.

Overland Park, Kansas, 66211, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001-7502, United States

Location

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

West Monroe, Louisiana, 71291-4452, United States

Location

Elman Retina Group, PA

Baltimore, Maryland, 21237, United States

Location

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, 01432-1191, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, 01605, United States

Location

Retina Specialists of Michigan

Grand Rapids, Michigan, 49546-3725, United States

Location

Mayo Clinic Department of Opthalmology

Rochester, Minnesota, 55905, United States

Location

The Retina Institute

St Louis, Missouri, 63128-1729, United States

Location

MaculaCare

New York, New York, 10021, United States

Location

Western Carolina Clinical Research, LLC

Asheville, North Carolina, 28803, United States

Location

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

Charlotte, North Carolina, 28210, United States

Location

Retina Associates of Cleveland, Inc

Beachwood, Ohio, 44122, United States

Location

Retina Vitreous Center

Edmond, Oklahoma, 73013-9791, United States

Location

Oregon Retina, LLP

Eugene, Oregon, 97401-7701, United States

Location

Retina Northwest, PC

Portland, Oregon, 97221, United States

Location

Southeastern Retina Associates

Chattanooga, Tennessee, 37421, United States

Location

Southeastern Retina Associates, PC

Knoxville, Tennessee, 37909, United States

Location

Austin Retina Associates

Austin, Texas, 78705-1169, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

Retinal Consultants of San Antonio

San Antonio, Texas, 78240, United States

Location

Spokane Eye Clinic

Spokane, Washington, 99204, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Results Point of Contact

• Title: Adam Glassman
• Organization: JAEB CENTER FOR HEALTH RESEARCH

drcrnet@jaeb.org

8139758690

Study Officials

• Clement Chan, MD

  Southern California Desert Retina Consultants, MC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Visual acuity and optical coherence tomography technicians will be masked to treatment group at all visits. The goal is for study participants to remain masked to their treatment group assignment, although it is likely that the gas bubble will be visible to participants in the pneumatic vitreolysis group. Investigators and study coordinators are not masked to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: October 16, 2018
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: September 21, 2022
• Results First Posted: October 28, 2021

Record last verified: 2022-09

Locations

US (41)