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Effects of Pneumatic Vitreolysis on Macular Hole (Protocol AH)

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ClinicalTrials.gov Identifier: NCT03677869
Recruitment Status : Recruiting
First Posted : September 19, 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 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.

Condition or disease Intervention/treatment Phase
Vitreomacular Traction (VMT) and Full-thickness Macular Holes (MH) Device: Intraocular gas (C3F8) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Intraocular gas (C3F8) injection
  1. Informed consent will be obtained.
  2. Eligibility will be assessed, including reading center confirmation of VMT and MH on OCT.
  3. Eligible eyes with VMT and MH will be treated with C3F8 injection.
  4. Follow-up visits will occur at 1, 4, 8, and 24 weeks and consist of visual acuity testing, ocular exam, and OCT.
Device: Intraocular gas (C3F8)
Intraocular gas (C3F8) injection




Primary Outcome Measures :
  1. proportion of eyes with full-thickness macular hole closure of inner retinal layers without rescue treatment [ Time Frame: at 8 weeks ]


Information from the National Library of Medicine

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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

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

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): NCT03677869


Contacts
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Contact: Adam R Glassman, MS 813-975-8690 drcrnet@jaeb.org

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

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT03677869     History of Changes
Other Study ID Numbers: DRCR.net Protocol AH
First Posted: September 19, 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

Keywords provided by Jaeb Center for Health Research:
Pneumatic Vitreolysis

Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases