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DRCR Protocol AH - Macular Hole

Effects Pneumatic Vitreolysis on Macular Hole

Study Description:

Condition or DiseaseIntervention / Treatment PhaseSponsor Status 
 Full-Thickness
Macular Hole
 Intraocular Gas C3F8 Jaeb Center for
Health Research
 Enrolling

 

 

 

Eyes with full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion 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 full-thickness MHs treated with PVL. Surgery would result in nearly 100% hole closure, 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.

  • Treatment Arm: Experimental intraocular gas (C3F8) injection.
  • Informed consent will be obtained.
  • Eligibility will be assessed, including reading center confirmation of MH on OCT.
  • Follow-up visits will occur at 1, 4, 8, and 24 weeks and consist of visual acuity testing, ocular exam, and OCT.

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.

Inclusion - Study Eye: 

  • Full-thickness macular hole that is ≤ 250 microns at the narrowest point, confirmed by central reading center. Presence of epiretinal membrane is neither a requirement nor exclusion.
  • Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 83 (20/25 or worse).
Exclusion - Study Eye:
  • 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 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.
  • 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).
  • History of prior gas injection, ocriplasmin injection, or intraocular injection for any reason.
  • History of prior vitrectomy.
  • 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.
  • 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.
  • History of YAG capsulotomy performed within 4 months prior to enrollment.
  • Aphakia or anterior chamber intraocular lens.
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
  • Uveitis.
  • 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.
  • Any contraindication to paracentesis (e.g., history of narrow angle glaucoma).
  • Lenticular or zonular instability.
Inclusion Criteria - General:
To be eligible, the following inclusion criteria must be met:
  • Age ≥ 18 years.
  • Able and willing to provide informed consent.
  • Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks).
  • For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks).
  • 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).
  • Able and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eye Exclusion.
  • At least one eye meets the Study Eye Criteria.
Exclusion Criteria - General:
A potential participant is not eligible if any of the following exclusion criteria are present:
  • 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).
  • 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. Known contraindication to any component of the treatment.
  • Known allergy to any drug used in the procedure prep (including povidone iodine).
  • 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.
  • Anticipated surgery requiring anesthesia within the 6 months following enrollment.
  • Participants cannot receive nitrous oxide until gas resolution.
  • For women of child-bearing potential: pregnant at the time of enrollment. 

Contact:
Beachwood Office - Janine Davis 216-831-5700    •    jdavis@retina-assoc.com
Middleburg Heights Office - Susan Rath 440-663-0022   •    srath@retina-assoc.com

To learn more:
https://clinicaltrials.gov/ct2/show/NCT03677869?term=drcr+ah&rank=1