Last updated on June 2019

Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Edema | age-related macular degeneration | Retinopathy | Diabetic Angiopathies | Diabetic Retinopathy | Macular Edema
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 18 years
  • Type 1 or type 2 diabetes
  • Diabetic Macular Edema (DME) in both eyes (with ophthalmoscopic evidence of center-involved DME)
  • Glated haemoglobin (HbA1c) <12 % in the last 3 months before patient inclusion
  • Failure of medical treatment considered for both eyes and conducted during at least 6 months defined as follows:
  • At least 4 intravitreal anti-VEGF injections given within the prior 6 months
  • ETDRS score 78 and 24 (approximate Snellen equivalent 20/32 to 20/320)
  • OCT (Optical Coherence Tomography) CSF (Central Subfield) thickness value (microns): Heidelberg Spectralis: 305 in women; 320 in men
  • Less than 5 letters gain in visual acuity (VA) after the initial Anti-VEGF treatment
  • Less than 25% decrease of CMT (Central Macular Thickness) after the initial Anti-VEGF treatment

Exclusion Criteria:

  • Any history of vitrectomy
  • Tractional DME: on OCT Optical Coherence Tomography), undetached posterior hyaloid membrane with anterior-posterior traction
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
  • Intraocular pressure 25 mmHg
  • Exam evidence of external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
  • Exam evidence of ocular toxoplasmosis
  • Aphakia
  • Ocular condition with visual acuity loss that, in the opinion of the investigator, would not improve from resolution of macular edema (e.g. foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition, etc.).
  • Condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 1 month prior to enrollment
  • History of macular laser photocoagulation within 3 months prior to enrollment.
  • History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment or anticipated need for PRP in the 6 months following enrollment into run-in phase.
  • History of major ocular surgery (including scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following enrollment.
  • History of cataract extraction within 3 months prior to enrollment
  • History of prior herpetic ocular infection
  • Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to inclusion or plans to do so in the next 4 months.
  • Steroid, anti-VEGF or pro-VEGF systemic treatment within 3 months prior to inclusion or anticipated use during the study
  • History of chronic renal failure requiring dialysis or kidney transplant.
  • Participation in an investigational trial that involved treatment with any drug that has not received regulatory approval for the indication being studied within 1 month of enrollment.
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next year.
  • Patient expected to move out of the area of the clinical center to an area not covered by another clinical center during the next year

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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