Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

Sponsor
University of Sao Paulo
Study ID
NCT01746563
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cardiovascular Diseases
  • Diabetic Angiopathies
  • Diabetic Retinopathy
  • Eye Diseases
  • Retinal Diseases
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection
  • Laser therapy — PROCEDURE
    Laser therapy

Study Details

To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).

Key Dates

First listed
Dec 11, 2012
Start date
May 31, 2011
Status verified
Dec 2012
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    Ranibizumab 0,05 mg intravitreal injection
  • Active Comparator: Laser Therapy
    Laser Therapy alone

Primary Outcome Measure

Macular Evaluation [ Time Frame: 6 Months ]

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