Full-thickness Macular Holes (MH) Clinical Trial
— Protocol AHOfficial title:
Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole
| Verified date | September 2022 |
| Source | Jaeb Center for Health Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | July 22, 2020 |
| Est. primary completion date | March 16, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Participant-Level Criteria Inclusion To be eligible, the following inclusion criteria must be met: 1. Age = 18 years • Participants < 18 years old are not being included because the condition is so rare in this age group that the diagnosis may be questionable. 2. At least one eye meets the study eye criteria 3. Able and willing to provide informed consent 4. Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks) 5. For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks) 6. Able and willing to position face down for at least 50% of the time for at least 4 days post-injection (to facilitate macular hole closure) 7. Able and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eye Exclusion A potential participant is not eligible if any of the following exclusion criteria are present: 8. 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) 9. Participation in an investigational trial within 30 days of enrollment 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 or device while participating in the study 10. Known contraindication to any component of the treatment 11. Known allergy to any drug used in the procedure prep (including povidone iodine) 12. 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 6 months following enrollment 13. Anticipated surgery requiring anesthesia within the 6 months following enrollment - Participants cannot receive nitrous oxide until gas resolution 13. 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 enrollment, the study eye will be selected by the investigator and participant before injection. The eligibility criteria for a study eye are as follows: Inclusion 1. Full-thickness macular hole that is = 250 microns at the narrowest point, confirmed by central reading center 2. 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 3. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 83 (20/25 or worse) Exclusion 4. 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. 5. 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) 6. History of prior gas injection, ocriplasmin injection, or intraocular injection for any reason 7. History of prior vitrectomy 8. 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 9. 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 10. History of YAG capsulotomy performed within 4 months prior to enrollment 11. Aphakia or anterior chamber intraocular lens 12. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis 13. Uveitis 14. 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 15. Any contraindication to paracentesis (e.g., history of narrow angle glaucoma) 16. Lenticular or zonular instability |
| Country | Name | City | State |
|---|---|---|---|
| United States | Western Carolina Clinical Research, LLC | Asheville | North Carolina |
| United States | Southeast Retina Center, PC | Augusta | Georgia |
| United States | Austin Retina Associates | Austin | Texas |
| United States | Retina Research Center | Austin | Texas |
| United States | Valley Eye Physicians and Surgeons | Ayer | Massachusetts |
| United States | Elman Retina Group, BA | Baltimore | Maryland |
| United States | Retina Associates of Cleveland, Inc. | Beachwood | Ohio |
| United States | Gailey Eye Clinic | Bloomington | Illinois |
| United States | Joslin Diabetes Center | Boston | Massachusetts |
| United States | Retinal Diagnostic Center | Campbell | California |
| United States | Charlotte Eye, Ear, Nose, and Throat Assoc., PA | Charlotte | North Carolina |
| United States | Southeastern Retina Associates | Chattanooga | Tennessee |
| United States | University of Illinois at Chicago Medical Center | Chicago | Illinois |
| United States | Retina Vitreous Center | Edmond | Oklahoma |
| United States | Oregon Retina, LLP | Eugene | Oregon |
| United States | National Ophthalmic Research Institute | Fort Myers | Florida |
| United States | Retina Specialists of Michigan | Grand Rapids | Michigan |
| United States | Atlantis Eye Care | Huntington Beach | California |
| United States | Raj K. Maturi, MD, PC | Indianapolis | Indiana |
| United States | University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr | Jacksonville | Florida |
| United States | Southeastern Retina Associates, PC | Knoxville | Tennessee |
| United States | Florida Retina Consultants | Lakeland | Florida |
| United States | Northern California Retina Vitreous Associates | Mountain View | California |
| United States | MaculaCare | New York | New York |
| United States | Illinois Retina Associates, SC | Oak Park | Illinois |
| United States | East Bay Retina Consultants, Inc. | Oakland | California |
| United States | Florida Retina Institute | Orlando | Florida |
| United States | Mid-America Retina Consultants, P.A. | Overland Park | Kansas |
| United States | Paducah Retinal Center | Paducah | Kentucky |
| United States | Southern California Desert Retina Consultants, MC | Palm Desert | California |
| United States | Southeast Eye Institute, PA dba Eye Associates of Pinellas | Pinellas Park | Florida |
| United States | Retina Northwest, PC | Portland | Oregon |
| United States | Mayo Clinic Department of Ophthalmology | Rochester | Minnesota |
| United States | The Retina Institute | Saint Louis | Missouri |
| United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
| United States | Retinal Consultants of San Antonio | San Antonio | Texas |
| United States | Thomas Eye Group | Sandy Springs | Georgia |
| United States | Retina Associates of Sarasota | Sarasota | Florida |
| United States | Sarasota Retina Institute | Sarasota | Florida |
| United States | Spokane Eye Clinic | Spokane | Washington |
| United States | Retina-Vitreous Surgeons of Central New York, PC | Syracuse | New York |
| United States | Carle Foundation Hospital | Urbana | Illinois |
| United States | Wolfe Eye Clinic | West Des Moines | Iowa |
| United States | Eye Associates of Northeast Louisiana dba Haik Humble Eye Center | West Monroe | Louisiana |
| United States | Vitreo-Retinal Associates, PC | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Jaeb Center for Health Research | National Eye Institute (NEI), National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy | at 8 weeks | ||
| Secondary | 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. | Baseline to 8 weeks | |
| Secondary | 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. | 8 weeks | |
| Secondary | Number of Eyes With Rescue Treatment Before the 8-week Visit | up to 8 Weeks | ||
| Secondary | Macular Hole Closure Without Rescue Vitrectomy | 8 Weeks | ||
| Secondary | Macular Hole Closure With Rescue Vitrectomy | 8 weeks | ||
| Secondary | No Macular Hole Closure and no Rescue Vitrectomy | 8 weeks | ||
| Secondary | No Macular Hole Closure Despite Rescue Vitrectomy | 8 weeks |