Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Purpose:

To evaluate whether intravitreal triamcinolone OR intravitreal ranibizumab can reduce occurrence of macular edema and visual acuity impairment following PRP

Population:

Estimated enrollment: 381

Age >= 18 years with diabetes type 1 or 2, with all of the following:

Inclusion Criteria of Study Eye: severe NPDR or PDR with plan for PRP, diabetic macular edema with central subfield thickness on OCT >250 microns, BCVA E-ETDRS letter score >=24 (20/320 or better), able to undergo PRP (media clarity, pupillary dilation, cooperation) and obtain fundus photos/OCT, may benefit from additional focal photocoagulation if prior focal has been done

Exclusion Criteria of Study Eye: sufficient prior PRP, macular edema due to other cause, ocular condition preventing visual acuity improvement after resolution of edema, other ocular condition that might affect macular edema or visual acuity during study, substantial cataract, hx of treatment for DME in past 4 months, hx of or upcoming major ocular surgery, hx of YAG cap, aphakia, IOP>=25, hx of steroid-induced IOP elevation requiring treatment, hx of ocular herpes, evidence of ocular toxoplasmosis/ PXF/ external ocular infection

Fellow Eye Criteria: IOP<=25, no hx of POAG, no hx of steroid-induced IOP elevation requiring treatment, no evidence of PXF

Study Design:

3 groups:

-       1. Intravitreal 0.5mg ranibizumab at baseline and 4 weeks

-       2. Intravitreal 4mg triamcinolone acetonide at baseline and sham at 4 weeks

-       3. Sham injection at baseline and 4 weeks (control)

Focal photocoagulation is given 3-10 days following injection, PRP either same day or within 14 days of baseline injection. Follow-up at 4, 14, 34, and 56 weeks.

Study Outcome:

Primary: Visual acuity

Secondary: Change in retinal thickening and volume, new vessels on fundus photographs, vitreous hemorrhage, additional PRP due to worsening PDR before 14 week visit

Study Results: Not yet available (in follow-up phase)

Note:

Study start date: 3/2007

Estimated study completion date: 12/2010

Estimated primary completion date: 2/2010

http://clinicaltrials.gov/ct2/show/NCT00445003