Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema

Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema

Purpose:

To find out which is better treatment for diabetic macular edema:

-       Laser alone

-       Laser + intravitreal triamcinolone

-       Laser + intravitreal ranibizumab

-       Intravitreal ranibizumab alone

Population:

Enrollment: 691

Age >=18 years, diabetes mellitus type 1 or 2

Study Eye Inclusion Criteria: BCVA E-ETDRS score 24-78 (20/32 – 20/320), definite central retinal thickening due to diabetic macular edema, OCT >=250 microns, media clarity, pupillary dilation, cooperation for adequate fundus photos, may benefit from additional focal photocoagulation if prior focal has been done

Study Eye Exclusion Criteria: 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 anticipated PRP, hx of or upcoming major ocular surgery, hx of YAG cap, aphakia, IOP>=25, hx of POAG, hx of steroid-induced IOP elevation requiring treatment, hx of ocular herpes, evidence of ocular toxoplasmosis/ PXF/ external ocular infection

Study Design:

  1. Sham injection + focal laser
  2. 0.5mg intravitreal ranibizumab + focal laser
  3. 0.5mg intravitreal ranibizumab + deferred focal
  4. 4mg intravitreal triamcinolone + focal laser

Laser is given 7-10 days after initial injection. Re-evaluation for re-treatment q4weeks x 3 years, unless injections are discontinued due to failure, then f/up q4months and treatment at investigator’s discretion.  Injections are repeated every 4 weeks with focal laser given post-injection q16weeks.

Study Outcomes:

Primary: Visual acuity

Secondary: Change in retinal thickening/volume measured on OCT, number of injections in first year

Study Results: Not yet available

Note:

Study Start Date: 3/2007

Estimated Study Completion Date: 3/2011

Estimated Primary Completion Date: 3/2011

http://clinicaltrials.gov/ct2/show/NCT00444600