Clinical trial NCT02055911: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetic Macular Edema
Keywords: diabetic macular edema
intravitreal ranibizumab
f retinal ganglion cell
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* Male or female patients, older than 18 years, who have signed an informed consent.
* Patients with Type 1 or Type 2 diabetes mellitus and prior diagnosis of diabetic macular edema (DME), who had not undergone any previous treatment, either pharmacological or laser photocoagulation.
* Patients with visual impairment due to DME whom, in the opinion of the investigator, would benefit from treating with IVR.

Exclusion Criteria:

* Known hypersensitivity to ranibizumab or any of its components.
* Previous participation in any clinical studies of investigational drugs within 1 month
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
* Pregnant or nursing (lactating) women.
* Inability to comply with study or follow-up procedures.

Primary outcomes:
measure: focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV)
timeFrame: at Baseline and Months 3, 6, 9, 12
Secondary outcomes:
measure: The mean change in BCVA
timeFrame: monthly, from baseline to Month 12
measure: the mean change in central macular thickness (CMT)
timeFrame: monthly, from baseline to Month 12
Other outcomes:
measure: assess adverse events
timeFrame: monthly, from Month 1 to Month 12
Locations:
city: São Paulo
country: Brazil
facility: Dept of Ophthalmology - UNIFESP/Hospital São Paulo
state: SP
Study officials:
affiliation: UNIFESP / HOSPITAL SÃO PAULO
name: Mauricio Maia, MD
role: PRINCIPAL_INVESTIGATOR
References: