Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema

Sponsor
Federal University of São Paulo
Study ID
NCT02055911
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections).

Study Details

To evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.

Key Dates

First listed
Feb 5, 2014
Start date
Mar 31, 2014
Status verified
Feb 2014
Primary completion
Mar 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections).

Primary Outcome Measure

focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV) [ Time Frame: at Baseline and Months 3, 6, 9, 12 ]

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