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Effects of Pneumatic Vitreolysis on Vitreomacular Traction (AG)

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ClinicalTrials.gov Identifier: NCT03647267
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief 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.

Condition or disease Intervention/treatment Phase
Vitreomacular Traction Device: Pneumatic Vitreolysis (C3F8 injection) Other: Observation Phase 3

Detailed Description:

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

Objectives

Primary

  1. To compare the proportion of eyes with foveal 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Visual acuity and optical coherence tomography technicians will be masked to treatment group at all visits. The goal is for study participants to remain masked to their treatment group assignment, although it is likely that the gas bubble will be visible to participants in the pneumatic vitreolysis group. Investigators and study coordinators are not masked to treatment group.
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Active Comparator: Pneumatic Vitreolysis
Participants randomized to the Pneumatic Vitreolysis arm will receive 0.3-mL intraocular injection of C3F8 gas.
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.

Placebo Comparator: Observation
Participants randomized to the observation group will receive a sham injection.
Other: Observation
No intervention; sham injection only




Primary Outcome Measures :
  1. Proportion of eyes with foveal vitreomacular traction release [ Time Frame: 24 Weeks ]
    Assessed by optical coherence tomography. Only for participants that do not undergo rescue treatment (e.g., vitrectomy or ocriplasmin). Determined by masked grader at the central reading center.


Secondary Outcome Measures :
  1. Proportion of eyes with foveal vitreomacular traction release (time-to-event analysis) [ Time Frame: Through 24 Weeks ]
    Assessed by optical coherence tomography by masked grader at a central reading center.

  2. Proportion of eyes with foveal vitreomacular traction release and vitreopapillary traction release [ Time Frame: 24 Weeks ]
    Assessed by optical coherence tomography by masked grader at a central reading center.

  3. Mean change in E-ETDRS visual acuity letter score [ Time Frame: From baseline at 24 weeks ]
    Visual acuity measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

  4. Proportion of eyes with at least 10-letter gain (increase) or loss (decrease) in visual acuity [ Time Frame: From baseline at 24 weeks ]
    Visual acuity measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

  5. Proportion of eyes receiving vitrectomy or for which vitrectomy is planned [ Time Frame: ≤ 24 Weeks ]
    Partipant must have vitrectomy before the 24-week visit or planned for at the 24-week visit with medical records confirming vitrectomy occurs within subsequent 12 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647267


Contacts
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Contact: Adam R Glassman, MS 8139758690 drcrstat2@jaeb.org

  Show 39 Study Locations
Sponsors and Collaborators
Jaeb Center for Health Research
National Institutes of Health (NIH)
National Eye Institute (NEI)
Investigators
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Study Chair: Clement Chan, MD Southern California Desert Retina Consultants, MC

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT03647267     History of Changes
Other Study ID Numbers: DRCR.net Protocol AG
U10EY014231 ( U.S. NIH Grant/Contract )
U10EY023207 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No