Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Vitreomacular Traction Clinical Trial

— AG  

Official title:

Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647267
• Other study ID #: DRCR.net Protocol AG
• Secondary ID: U10EY014231U10EY
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2018
• Est. completion date: August 6, 2020

Study information

• Verified date: September 2022
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.

Description:

Investigational Device: 0.3-mL intraocular gas (C3F8) injection

Objectives

Primary

1. To compare the proportion of eyes with central VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole.

Secondary

2. To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection.

Study Design: Multi-center, randomized clinical trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 6, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least one eye meets the study eye criteria listed below.

2. Able and willing to provide informed consent.

3. Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks).

4. For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks).

5. 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:

6. 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)

7. Participation in an investigational trial within 30 days of randomization 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/device while participating in the study

8. Known contraindication to any component of the treatment

9. Known allergy to any drug used in the procedure prep (including povidone iodine)

10. 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 next 6 months following randomization

11. Anticipated surgery requiring anesthesia within the next 6 months following randomization

• Participants cannot receive nitrous oxide until gas resolution

12. 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 randomization, the study eye will be selected by the investigator and participant before randomization.

The eligibility criteria for a study eye are as follows:

Inclusion

1. 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 Note: presence of epiretinal membrane is neither a requirement nor exclusion.

2. Decreased visual function (e.g. metamorphopsia or other visual symptom) that is attributed to VMT.

Examples of visual symptoms include:

a) Distortion and/or reduction in visual acuity b) Recognized difficulty with reading, driving, or using a computer c) Patient recognized interference with quality of life because of a and/or b.

c. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 78 (20/32 or worse) d. Investigator and participant willing to wait 6 months before surgical intervention, provided visual acuity remains stable

• An eye that requires prompt treatment for VMT should not be enrolled

Exclusion e. 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 f. 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) g. History of prior gas injection, ocriplasmin injection, or intraocular injection for any reason h. History of prior vitrectomy i. History of uncontrolled glaucoma

• IOP must be <30 mmHg, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible j. 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 randomization k. History of YAG capsulotomy performed within 4 months prior to randomization l. Aphakia or anterior chamber intraocular lens m. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis n. Uveitis o. Presence of any macular hole or lamellar hole (according to reading center grading) p. 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.

q. Any contraindication to paracentesis (e.g., history of narrow angle glaucoma) r. Lenticular or zonular instability

Related Conditions & MeSH terms

• Vitreomacular Traction

Intervention

Device:
• Pneumatic Vitreolysis (C3F8 injection)
Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.

Other:
• Observation
No intervention; sham injection only

Locations

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, PA	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, M.D., P.C.	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, S.C.	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 Opthalmology	Rochester	Minnesota
United States	The Retina Institute	Saint Louis	Missouri
United States	Retinal Consultants of San Antonio	San Antonio	Texas
United States	Thomas Eye Group	Sandy Springs	Georgia
United States	Sarasota Retina Institute	Sarasota	Florida
United States	Spokane Eye Clinic	Spokane	Washington
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

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy		at 24 Weeks
Secondary	Number of Eyes With Rescue Treatment Before the 24-week Visit		up to 24 weeks
Secondary	Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit	scheduled rescue vitrectomy must be completed within the subsequent 12 weeks.	through 24 Weeks
Secondary	Number of Eyes With Central Vitreomacular Traction Status		up to 24 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 24 weeks