Study Detail: DRCR S
Trial Description Summary
A Phase III prospective, multicenter randomized clinical trial to determine if visual acuity at 2 years in eyes with PDR that receive ranibizumab with deferred PRP are non-inferior to those eyes that receive standard PRP therapy.
This clinical trial is to determine if vision changes in patients that have PDR (Proliferative Diabetic Retinopathy) ranibizumab without laser therapy compared to the group who only receive standard of care laser therapy.
Basic Trial Information
Phase: III
Disease Status: Type 1 or Type 2 Diabetics
Age: 18 or older
Sponsor: DRCRnet
Protocol #: S
Status: Enrolling
Study Duration: 5 year
Eligibility Criteria
Inclusion Criteria
- One eye which investigator intends to manage with PRP alone but the PRP can be deferred for at least 4 weeks in the setting of intravitreal ranibizumab
- Snellen 20/320 or better upon randomization
Exclusion Criteria
- History of PRP (defined as greater than 100 burns outside of posterior pile)
- TRD involving the macula
- Exam evidence of ange neovascularization
- Macular edema from anything other than DME
- Substantial cataract likely to decrease VA to 20/40 or worse (3 lines)
- Intravitreal anti-VEGF in past 2 months
- Intravitreal steriod in last 4 months
- Major acular surgery in prior 4 months or anticipated in the next 6 months
- YAG capsulotomy 2 months prior to randomization
- Uncontrolled glaucoma
- On renal dialysis
- Post transplant (or transplant candidate)
- Poor glycemic control within last 4 months requireing intensive insulin treatment
- Uncontrolled blood pressure (> 180/110)
- Within 4 months prior to randomization: MI, stroke, TIA, acute CHF, other cardiac event requiring hospitalization
- Within 4 months prior to randomization systemic anti or pro VEGF
- Women of child bearing potential, pregnant, lactating or intending to become pregnant in next 3 years
- Planning on moving outside of area in next 3 years
Other inclusion/exclusion criteria per protocol to be screened by the Clinical Coordinator
Study Title
Prompt PRP versus IV ranibizumab with deferred PRP for PDR
Trial Contact Information
Site: Beachwood or Middleburgh Heights office
Study Coordinator: 216/831-5704 ext. 253