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.
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
- Conditions the study is for
- Vitreomacular Traction (VMT), Full-thickness Macular Holes (MH)
- What is being tested?
- Intraocular gas (C3F8)
- Type of treatment
- Injection or infusion, Medical device
- 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
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 group | Role | What they receive |
|---|---|---|
| Pneumatic vitreolysis (PVL) | Experimental | Pneumatic 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.
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy
Measured: at 8 weeks
Secondary outcomes (7)
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
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
Number of Eyes With Rescue Treatment Before the 8-week Visit
Measured: up to 8 Weeks
Macular Hole Closure Without Rescue Vitrectomy
Measured: 8 Weeks
Macular Hole Closure With Rescue Vitrectomy
Measured: 8 weeks
No Macular Hole Closure and no Rescue Vitrectomy
Measured: 8 weeks
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.
- First posted19 Sep 2018
- Study start14 Nov 2018
- Primary completion16 Mar 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitreomacular Traction (VMT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Calvin E Mein, MD, Study chair, Retinal Consultants of San Antonio
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole
- ClinicalTrials.gov ID
- NCT03677869
- Acronym / sponsor ID
- Protocol AH / DRCR.net Protocol AH
- Keywords
- Pneumatic Vitreolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumatic vitreolysis (PVL) | Experimental | Device: Intraocular gas (C3F8)Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
- 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)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular gas (C3F8)Intraocular gas (C3F8) injection | Device | Pneumatic vitreolysis (PVL) |
Primary outcome
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy
Time frame: at 8 weeks
7 secondary outcomes
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
Time frame: Baseline to 8 weeks
E-ETDRS Visual Acuity Letter Score
Time frame: 8 weeks
Number of Eyes With Rescue Treatment Before the 8-week Visit
Time frame: up to 8 Weeks
Macular Hole Closure Without Rescue Vitrectomy
Time frame: 8 Weeks
Macular Hole Closure With Rescue Vitrectomy
Time frame: 8 weeks
No Macular Hole Closure and no Rescue Vitrectomy
Time frame: 8 weeks
No Macular Hole Closure Despite Rescue Vitrectomy
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calvin E Mein, MD study chair
Retinal Consultants of San Antonio
45 sites in 1 country: see every site and its status.
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?
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.