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Vitreomacular Traction (VMT)Protocol AHNCT03677869

Effects of Pneumatic Vitreolysis on Macular Hole

A study testing Intraocular gas (C3F8) in people with Vitreomacular Traction (VMT) and Full-thickness Macular Holes (MH), run by Jaeb Center for Health Research at 45 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 vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intraocular gas (C3F8)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
45 sitesUnited States
Study dates
14 Nov 2018to 22 Jul 2020
Phase
Interventional
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

  • Full-thickness macular hole that is ≤ 250 microns at the narrowest point, confirmed by central reading center
  • 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
  • Presence of epiretinal membrane is neither a requirement nor exclusion
  • Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 83 (20/25 or worse) Exclusion
  • 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).
Show all 21Show fewer
  • Presence of drusen is acceptable; however, eyes with geographic atrophy or neovascular age-related macular degeneration involving the macula are excluded.
  • 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)
  • History of prior gas injection, ocriplasmin injection, or intraocular injection for any reason
  • History of prior vitrectomy
  • History of uncontrolled glaucoma
  • Intraocular pressure must be < 30 mmHg, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible
  • 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 enrollment
  • History of YAG capsulotomy performed within 4 months prior to enrollment
  • Aphakia or anterior chamber intraocular lens
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
  • Uveitis
  • 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)
  • Lenticular or zonular instability

Who cannot join

None listed.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 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, BA

    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, MD, PC

    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, SC

    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 Ophthalmology

    Rochester, Minnesota, 55905

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • Retina Associates of Sarasota

    Sarasota, Florida, 34233-1261

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Spokane Eye Clinic

    Spokane, Washington, 99204

  • The Retina Institute

    St Louis, Missouri, 63128-1729

  • Retina-Vitreous Surgeons of Central New York, PC

    Syracuse, New York, 13224

  • Carle Foundation Hospital

    Urbana, Illinois, 61801-2529

  • 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: Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole

Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.

Read the detailed description

The objective of this trial is to obtain estimates of the proportion of eyes with MH closure of the inner retinal layers for eyes with VMT and full-thickness MHs treated with PVL. Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary. Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.

Being tested
Intraocular gas (C3F8)
Keywords
Pneumatic Vitreolysis

What participants receive

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

  • Intraocular gas (C3F8)Device

    Intraocular gas (C3F8) injection

Study groups in NCT03677869
Study groupRoleWhat they receive
Pneumatic vitreolysis (PVL)ExperimentalPneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
Receives: Device: Intraocular gas (C3F8)

What is being measured

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

  1. Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy

    Measured: at 8 weeks

Secondary outcomes (7)

  1. 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 8 weeks

  2. E-ETDRS Visual Acuity Letter Score

    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: 8 weeks

  3. Number of Eyes With Rescue Treatment Before the 8-week Visit

    Measured: up to 8 Weeks

  4. Macular Hole Closure Without Rescue Vitrectomy

    Measured: 8 Weeks

  5. Macular Hole Closure With Rescue Vitrectomy

    Measured: 8 weeks

  6. No Macular Hole Closure and no Rescue Vitrectomy

    Measured: 8 weeks

  7. No Macular Hole Closure Despite Rescue Vitrectomy

    Measured: 8 weeks

Timeline

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

  1. First posted19 Sep 2018
  2. Study start14 Nov 2018
  3. Primary completion16 Mar 2020
  4. Study completion22 Jul 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677869
Sponsor's protocol ID
DRCR.net Protocol AH
Other IDs
U10EY014231
Acronym
Protocol AH
Status last verified
Sep 2022
First submitted
18 Sep 2018
Last updated
19 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 study testing Intraocular gas (C3F8) in people with Vitreomacular Traction (VMT) and Full-thickness Macular Holes (MH), run by Jaeb Center for Health Research at 45 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 21 inclusion and 0 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 19 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 45 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 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 Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy (time frame: at 8 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 NCT03677869.

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 19 Sep 2022.

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