Spots Global Cancer Trial Database for Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema
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Trial Identification
Brief Title: Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema
Official Title: Retinal Ganglion Cell Function After Repeated Intravitreous Ranibizumab in Diabetic Macular Edema
Study ID: NCT02055911
Conditions
Interventions
Study Description
Brief Summary: To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.
Detailed Description: * Ranibizumab can be a safe treatment for diabetic macular edema regarding maintenance of retinal ganglion cell function after repeated intravitreal injections. * To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function. * The primary endpoint for the study will be the changes in full-field and focal macular photopic negative response (PhRN) amplitude (in µV) over time, from baseline to month 12.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dept of Ophthalmology - UNIFESP/Hospital São Paulo, São Paulo, SP, Brazil
Contact Details
Name: Mauricio Maia, MD
Affiliation: UNIFESP / HOSPITAL SÃO PAULO
Role: PRINCIPAL_INVESTIGATOR
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