Diabetic Retinopathy Clinical Research Protocol V (DRCR V)

Active Clinical Trials // Feb 14 2017

sponsored by JAEB

 

Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual Acuity

Principal Investigator: Justin Gottlieb, MD

Study Coordinator(s):

  • Kris Dietzman
  • Chris Smith

Study Objective: The primary objective of the protocol is to compare the safety and efficacy of three treatment strategies in eyes with central-involved DME and good visual acuity.

Study Design: Randomized, multi-center clinical trial

Major Eligibility Criteria:

  • Age ≥ 18 years
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Investigator is willing to use the study anti-VEGF drug (2.0 mg aflibercept) for the non-study eye, if anti-VEGF treatment is needed
  • DME confirmed on OCT at two consecutive visits within 1 to 28 days:
    • Zeiss Cirrus: ≥ 290 in women, and ≥ 305 in men
    • Heidelberg Spectralis: ≥ 305 in women, and ≥ 320 in men
  • Visual acuity letter score in study eye ≥ 79(approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days.
  • The investigator is comfortable with the eye being randomized to any of the three treatment groups (observation, laser, or anti-VEGF initially).
  • Media clarity, papillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.

Exclusion Criteria: (study eye only)

  • Macular edema is considered to be due to a cause other than DME.
  • An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
  • An ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis, or other ocular inflammatory disease, neovascular glaucoma, etc)
  • Cataract that, in the opinion of the investigator, may alter visual acuity during the course of the study
  • Any history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF).
  • History of topical steroid or NSAID treatment within 30 days prior to randomization
  • History of intravitreal or peribulbar corticosteroid within 4 months prior to randomization for an ocular condition other than DME.
  • Any history of or anticipated need for intravitreal anti-VEGF within the next 6 months for an ocular condition other than DME 9e.g. choroidal neovascularization, central retinal vein occlusion, PDR). History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
  • Any history of vitrectomy.
  • History of major ocular surgery within prior 4 months or anticipated within the next 6 months following randomization
  • History of YAG capsulotomy performed within 2 months prior to randomization Aphakia
  • Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis

Treatment Groups

Study participants will be assigned randomly to one of the following three groups:

  • Prompt laser + deferred anti-VEGF
  • Observation + deferred anti-VEGF, and
  • Prompt anti-VEGF

Duration of Follow-up: Duration of follow-up is 2 years

Follow up Schedule

  • Prompt anti-VEGF group:
    • visits every 4 weeks during first 24 weeks
    • visits every 4 to 16 weeks thereafter depending on treatment administered.
  • Deferred anti-VEGF groups (prompt focal/grid photocoagulation and observation groups):
    • visits at week 8 and 16
    • followed by visits every 16 weeks thereafter.*
  • For the deferred groups, the follow-up visit interval will be decreased if macular edema is worsening on OCT or visual acuity drops 5 to 9 letters, to assess for continued vision loss needing anti-VEGF treatment. Once anti-VEGF is initiated, visits will be every 4 weeks during the first 24 weeks of treatment and every 4 to 16 weeks thereafter.

For more information contact Kris Dietzman at 608-263-9035, or Chris Smith at 608-263-7169