DRCR (Diabetic Retinopathy Clinical Research) Protocol AB
Intravitreous anti-VEGF vs. prompt vitrectomy for vitreous hemorrhage from PDR

Study Objectives:

The objectives of this study are to:

1) Evaluate and compare visual acuity outcomes over the course of the study of a prompt vitrectomy + PRP regimen and an intravitreous aflibercept regimen in eyes with VH from PDR for which intervention is deemed necessary, and

2) Characterize the follow-up course for the two treatment regimens, including but not limited to post-operative complications for the vitrectomy group, and number of injections needed and percent requiring vitrectomy in intravitreous aflibercept group.

The potential study participant must have at least one eye meeting all of the inclusion criteria (a-c) and none of the exclusion criteria (d-p) listed below.  A study participant can have two study eyes only if both are eligible at the time of randomization.  For study participants with two eligible eyes, the logistical complexities of the protocol must be considered for each individual prior to randomizing both eyes.

Inclusion Criteria:
  • a) Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal ranibizumab, in the investigator’s judgment.
  • b) Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score _ 24 (approximate Snellen equivalent 20/320) on the day of randomization.
  • c) Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT.
Exclusion Criteria:

The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
  • d) History of prior panretinal photocoagulation (prior PRP is defined as _100 burns outside of the posterior pole)
  • e) Tractional retinal detachment involving the macula.
  • f ) Exam evidence of neovascularization of the angle (neovascularization of the iris alone is not an exclusion if it does not preclude deferring PRP for at least 4 weeks in the investigator’s judgment).
  • g) If macular edema is present, it is considered to be primarily due to a cause other than diabetic macular edema.
  • h) An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.) A vitreous or preretinal hemorrhage is not an exclusion if it is out of the visual axis and in the investigator’s judgment is not having any affect on visual acuity.
  • i) Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye were otherwise normal).
  • j) History of intravitreal anti-VEGF treatment at any time in the past 2 months.
  • k) History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months.
  • l) History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
  • m) History of YAG capsulotomy performed within 2 months prior to randomization.
  • n) Aphakia.
  • o) Uncontrolled glaucoma (in investigator’s judgment).
  • p) Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
Treatment Groups

Study eyes will be assigned randomly (1:1) to one of the following two groups:
  1. Prompt panretinal photocoagulation
  2. Intravitreal 0.5 mg ranibizumab with deferred panretinal photocoagulation
Study participants with two study eyes will be randomized to prompt PRP in one eye and ranibizumab with deferred PRP in the other eye.
Principal Investigator:

Kevin J. Blinder, MD

Sub Investigator:

Thomas K. Krummenacher, MD

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