Effects of Pneumatic Vitreolysis on Macular Hole (Protocol AH)

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.

Study Overview

• Status: Completed
• Conditions: Vitreomacular Traction (VMT); Full-thickness Macular Holes (MH)
• Intervention / Treatment: Device: Intraocular gas (C3F8)

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center
    • Huntington Beach, California, United States, 92647-8693
      • Atlantis Eye Care
    • Mountain View, California, United States, 94040-4123
      • Northern California Retina Vitreous Associates
    • Oakland, California, United States, 94609-3028
      • East Bay Retina Consultants, Inc.
    • Palm Desert, California, United States, 92211
      • Southern California Desert Retina Consultants, MC
  • Florida
    • Fort Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute
    • Jacksonville, Florida, United States, 32209
      • University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr
    • Lakeland, Florida, United States, 33805
      • Florida Retina Consultants
    • Orlando, Florida, United States, 32806-1101
      • Florida Retina Institute
    • Pinellas Park, Florida, United States, 33782-4418
      • Southeast Eye Institute, PA dba Eye Associates of Pinellas
    • Sarasota, Florida, United States, 34239
      • Sarasota Retina Institute
    • Sarasota, Florida, United States, 34233-1261
      • Retina Associates of Sarasota
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center, PC
    • Sandy Springs, Georgia, United States, 30328
      • Thomas Eye Group
  • Illinois
    • Bloomington, Illinois, United States, 61704-2484
      • Gailey Eye Clinic
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago Medical Center
    • Oak Park, Illinois, United States, 60304
      • Illinois Retina Associates, SC
    • Urbana, Illinois, United States, 61801-2529
      • Carle Foundation Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj K. Maturi, MD, PC
  • Iowa
    • West Des Moines, Iowa, United States, 50266-7705
      • Wolfe Eye Clinic
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Mid-America Retina Consultants, P.A.
  • Kentucky
    • Paducah, Kentucky, United States, 42001-7502
      • Paducah Retinal Center
  • Louisiana
    • West Monroe, Louisiana, United States, 71291-4452
      • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Elman Retina Group, BA
  • Massachusetts
    • Ayer, Massachusetts, United States, 01432-1191
      • Valley Eye Physicians and Surgeons
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
    • Worcester, Massachusetts, United States, 01605
      • Vitreo-Retinal Associates, PC
  • Michigan
    • Grand Rapids, Michigan, United States, 49546-3725
      • Retina Specialists Of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Department of Ophthalmology
  • Missouri
    • Saint Louis, Missouri, United States, 63128-1729
      • The Retina Institute
  • New York
    • New York, New York, United States, 10021
      • MaculaCare
    • Syracuse, New York, United States, 13224
      • Retina-Vitreous Surgeons of Central New York, PC
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Clinical Research, LLC
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye, Ear, Nose, and Throat Assoc., PA
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Retina Associates of Cleveland, Inc.
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013-9791
      • Retina Vitreous Center
  • Oregon
    • Eugene, Oregon, United States, 97401-7701
      • Oregon Retina, LLP
    • Portland, Oregon, United States, 97221
      • Retina Northwest, PC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Southeastern Retina Associates
    • Knoxville, Tennessee, United States, 37909
      • Southeastern Retina Associates, PC
  • Texas
    • Austin, Texas, United States, 78705
      • Retina Research Center
    • Austin, Texas, United States, 78705-1169
      • Austin Retina Associates
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
    • San Antonio, Texas, United States, 78240
      • Retinal Consultants of San Antonio
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pneumatic vitreolysis (PVL); Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.	Device: Intraocular gas (C3F8); Intraocular gas (C3F8) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy	at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of Eyes With Rescue Treatment Before the 8-week Visit		up to 8 Weeks
Macular Hole Closure Without Rescue Vitrectomy		8 Weeks
Macular Hole Closure With Rescue Vitrectomy		8 weeks
No Macular Hole Closure and no Rescue Vitrectomy		8 weeks
No Macular Hole Closure Despite Rescue Vitrectomy		8 weeks

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: National Eye Institute (NEI); National Institutes of Health (NIH)
• Investigators: Study Chair: Calvin E Mein, MD, Retinal Consultants of San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): July 22, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pneumatic Vitreolysis
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: DRCR.net Protocol AH; U10EY014231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes