Microperimetry and Optical Coherence Tomography (OCT) With Lucentis for Diabetic Macular Edema (DME)

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study ID
NCT00885794
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    3 intravitreal injection every 5 weeks

Study Details

Diabetic maculopathy is the leading cause of visual impairment in the working-age population in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is treated by laser, vitreous surgery, and intravitreal cortisone application. Still 50% of the cases do not respond to the treatment. Recently intraocular anti-VEGF-treatment with ranibizumab (Lucentis®, Novartis) in diabetic macular edema has proven efficacy to last over a period of 3 to 6 months. Still, the optimal dosage for those intravitreal injections still has to be found, because frequent injections are necessary. The measurement of visual acuity is inadequate to quantify in detail the visual impairment. Using the newest technology of a high-definition optical coherence tomography (Cirrus-OCT, Carl Zeiss Meditec Inc.) to determine the retinal thickness, and a miroperimetry (MP-1, Nidek Technologies) to determine retinal sensitivity, we hope to find the optimal dosage of intravitreal anti-VEGF treatment in diabetic macular edema. Study objective: To determine the dose response of 0.5mg and 1.0mg ranibizumab (Lucentis®, Novartis Pharma) intravitreal injection in subjects with resistant diabetic macular edema and evaluate safety and tolerability.

Key Dates

First listed
Apr 22, 2009
Start date
May 31, 2008
Status verified
Jun 2011
Primary completion
May 31, 2011
Completion
May 31, 2012

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 0.5 mg Ranibizumab
    3 intravitreal injections of 0.5 mg Ranibizumab every 5 weeks
  • Experimental: 1.0 mg of Ranibizumab
    3 intravitreal injections of 1.0mg Ranibizumab every 5 weeks

Primary Outcome Measure

Retinal thickness [ Time Frame: at 3 months ]

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