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Vitreomacular TractionPhase 3AGNCT03647267

Effects of Pneumatic Vitreolysis on Vitreomacular Traction

A Phase 3 study testing Pneumatic Vitreolysis (C3F8 injection) and Observation in people with Vitreomacular Traction, run by Jaeb Center for Health Research at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitreomacular Traction
What is being tested?
Pneumatic Vitreolysis (C3F8 injection) and Observation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
41 sitesUnited States
Study dates
16 Oct 2018to 6 Aug 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
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  • Decreased visual function (e.g. metamorphopsia or other visual symptom) that is attributed to VMT.
  • Examples of visual symptoms include:
  • 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.
  • 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.
  • Any contraindication to paracentesis (e.g., history of narrow angle glaucoma) r. Lenticular or zonular instability

Who cannot join

  • 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)
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  • 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:

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Western Carolina Clinical Research, LLC

    Asheville, North Carolina, 28803

  • Southeast Retina Center, PC

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705-1169

  • Retina Research Center

    Austin, Texas, 78705

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts, 01432-1191

  • Elman Retina Group, PA

    Baltimore, Maryland, 21237

  • Retina Associates of Cleveland, Inc

    Beachwood, Ohio, 44122

  • Gailey Eye Clinic

    Bloomington, Illinois, 61704-2484

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Retinal Diagnostic Center

    Campbell, California, 95008

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

    Charlotte, North Carolina, 28210

  • Southeastern Retina Associates

    Chattanooga, Tennessee, 37421

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013-9791

  • Oregon Retina, LLP

    Eugene, Oregon, 97401-7701

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Retina Specialists of Michigan

    Grand Rapids, Michigan, 49546-3725

  • Atlantis Eye Care

    Huntington Beach, California, 92647-8693

  • Raj K. Maturi, M.D., P.C.

    Indianapolis, Indiana, 46290

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

    Jacksonville, Florida, 32209

  • Southeastern Retina Associates, PC

    Knoxville, Tennessee, 37909

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040-4123

  • MaculaCare

    New York, New York, 10021

  • Illinois Retina Associates, S.C.

    Oak Park, Illinois, 60304

  • East Bay Retina Consultants, Inc

    Oakland, California, 94609-3028

  • Florida Retina Institute

    Orlando, Florida, 32806-1101

  • Mid-America Retina Consultants, P.A.

    Overland Park, Kansas, 66211

  • Paducah Retinal Center

    Paducah, Kentucky, 42001-7502

  • Southern California Desert Retina Consultants, MC

    Palm Desert, California, 92211

  • Southeast Eye Institute, PA dba Eye Associates of Pinellas

    Pinellas Park, Florida, 33782-4418

  • Retina Northwest, PC

    Portland, Oregon, 97221

  • Mayo Clinic Department of Opthalmology

    Rochester, Minnesota, 55905

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Spokane Eye Clinic

    Spokane, Washington, 99204

  • The Retina Institute

    St Louis, Missouri, 63128-1729

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266-7705

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana, 71291-4452

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction

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.

Read the 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

Being tested
Pneumatic Vitreolysis (C3F8 injection), Observation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • ObservationOther

    No intervention; sham injection only

Study groups in NCT03647267
Study groupRoleWhat they receive
Pneumatic VitreolysisActive comparatorParticipants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.
Receives: Device: Pneumatic Vitreolysis (C3F8 injection)
ObservationPlacebo comparatorParticipants randomized to the observation group will receive a sham injection.
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy

    Measured: at 24 Weeks

Secondary outcomes (4)

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

    Measured: up to 24 weeks

  2. Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit

    scheduled rescue vitrectomy must be completed within the subsequent 12 weeks.

    Measured: through 24 Weeks

  3. Number of Eyes With Central Vitreomacular Traction Status

    Measured: up to 24 weeks

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

    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.

    Measured: Baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start16 Oct 2018
  3. Primary completion6 Aug 2020
  4. Study completion6 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647267
Sponsor's protocol ID
DRCR.net Protocol AG
Other IDs
U10EY014231, U10EY023207
Acronym
AG
Status last verified
Sep 2022
First submitted
23 Aug 2018
Last updated
21 Sep 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pneumatic Vitreolysis (C3F8 injection) and Observation in people with Vitreomacular Traction, run by Jaeb Center for Health Research at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy (time frame: at 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03647267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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