Microperimetry and Optical Coherence Tomography (OCT) With Lucentis for Diabetic Macular Edema (DME)
Status:
Unknown status
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery