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Phase 3 N=345 Randomized Double-blind Treatment

Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy · Diabetic Macular Edema

Enrolled (actual)
345
Serious AEs
10.4%
Results posted
Jul 2011
Primary outcome: Primary: Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks — -4; 1; 2 Letter Score — p=<.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Ranibizumab (Drug); Triamcinolone Acetonide (Drug); Sham injection (Behavioral); Focal/grid laser (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jaeb Center for Health Research
Primary completion
Oct 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks
-4; 1; 2 <.001 sig
SECONDARY
Additional Treatments for Diabetic Macular Edema
14; 12; 9; 1; 0; 3
SECONDARY
Change in Optical Coherence Tomography Central Subfield Thickness
362; 312; 265 <.01 sig
SECONDARY
Total Optical Coherence Tomography Retinal Volume
9.7; 9.3; 7.9
SECONDARY
Change in Visual Acuity From Baseline
-6; -4; -5 0.44
SECONDARY
Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema
28; 23; 17
SECONDARY
Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema
71; 48; 45
SECONDARY
Change in Optical Coherence Tomography Retinal Volume
0.1; -0.4; -1.3 0.001 sig

Summary

The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is possible that one or both of the types of injections will prevent vision loss after PRP treatment. However, it is not known whether the benefits of the injections will outweigh the risks. It is possible that because of side effects, the injections may not be as good as laser alone in treating the diabetic retinopathy.

Eligibility Criteria

General Inclusion Criteria

  • Age >= 18 years
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Fellow eye (if not a study eye) meets criteria.
  • Able and willing to provide informed consent. Study Eye Inclusion Criteria Subjects may have one or two study eyes. Subjects with two study eyes will be randomly assigned to receive sham injection at baseline and 4 weeks in one eye and either ranibizumab or triamcinolone in the other eye.
  • Presence of severe nonproliferative or proliferative diabetic retinopathy for which investigator intends to complete panretinal photocoagulation within 49 days after randomization.
  • Diabetic macular edema(DME) present on clinical exam and central subfield thickness on Optical Coherence Tomography (OCT) >250 microns, within 8 days of randomization.
  • Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score >=24 (i.e., 20/320 or better), within 8 days of randomization.
  • Media clarity, pupillary dilation, and subject cooperation sufficient to administer panretinal photocoagulation and obtain adequate fundus photographs and OCT.
  • If prior macular photocoagulation has been performed, the investigator believes that the study eye may possibly benefit from additional focal photocoagulation.

General Exclusion Criteria

  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
  • Known allergy to any component of the study drugs.
  • Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
  • Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
  • Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
  • Systemic anti-vascular endothelial growth factor(VEGF) or pro-VEGF treatment within 4 months prior to randomization.
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
  • Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.

Study Eye Exclusion Criteria, Study eye only:

  • Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization.
  • Macular edema is considered to be due to a cause other than diabetic macular edema.
  • An ocular condition is present such that, in the opinion of the investigator, preventing visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition).
  • An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or 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.).
  • 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 was otherwise normal).
  • History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
  • History of major ocular surgery (including vitrectomy, cataract ext
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00445003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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