Clinical trial NCT03677869: Effects of Pneumatic Vitreolysis on Macular Hole
Official title: Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreomacular Traction (VMT)
Full-thickness Macular Holes (MH)
Keywords: Pneumatic Vitreolysis
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
First posted: 2018-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy
timeFrame: at 8 weeks
Secondary outcomes:
measure: Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
timeFrame: Baseline to 8 weeks
measure: E-ETDRS Visual Acuity Letter Score
timeFrame: 8 weeks
measure: Number of Eyes With Rescue Treatment Before the 8-week Visit
timeFrame: up to 8 Weeks
measure: Macular Hole Closure Without Rescue Vitrectomy
timeFrame: 8 Weeks
measure: Macular Hole Closure With Rescue Vitrectomy
timeFrame: 8 weeks
measure: No Macular Hole Closure and no Rescue Vitrectomy
timeFrame: 8 weeks
measure: No Macular Hole Closure Despite Rescue Vitrectomy
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eye Care
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants, Inc.
state: California
city: Palm Desert
country: United States
facility: Southern California Desert Retina Consultants, MC
state: California
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Pinellas Park
country: United States
facility: Southeast Eye Institute, PA dba Eye Associates of Pinellas
state: Florida
city: Sarasota
country: United States
facility: Retina Associates of Sarasota
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Sandy Springs
country: United States
facility: Thomas Eye Group
state: Georgia
city: Bloomington
country: United States
facility: Gailey Eye Clinic
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago Medical Center
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates, SC
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD, PC
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Overland Park
country: United States
facility: Mid-America Retina Consultants, P.A.
state: Kansas
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: West Monroe
country: United States
facility: Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
state: Louisiana
city: Baltimore
country: United States
facility: Elman Retina Group, BA
state: Maryland
city: Ayer
country: United States
facility: Valley Eye Physicians and Surgeons
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Worcester
country: United States
facility: Vitreo-Retinal Associates, PC
state: Massachusetts
city: Grand Rapids
country: United States
facility: Retina Specialists of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Department of Ophthalmology
state: Minnesota
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: New York
country: United States
facility: MaculaCare
state: New York
city: Syracuse
country: United States
facility: Retina-Vitreous Surgeons of Central New York, PC
state: New York
city: Asheville
country: United States
facility: Western Carolina Clinical Research, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose, and Throat Assoc., PA
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland, Inc.
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Retina, LLP
state: Oregon
city: Portland
country: United States
facility: Retina Northwest, PC
state: Oregon
city: Chattanooga
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Knoxville
country: United States
facility: Southeastern Retina Associates, PC
state: Tennessee
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
Study officials:
affiliation: Retinal Consultants of San Antonio
name: Calvin E Mein, MD
role: STUDY_CHAIR
References: