Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema
NCT ID: NCT02055911
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2014-03-31
2015-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Federal University of São Paulo
OTHER
Responsible Party
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Mauricio Maia
Professor
Principal Investigators
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Mauricio Maia, MD
Role: PRINCIPAL_INVESTIGATOR
UNIFESP / HOSPITAL SÃO PAULO
Locations
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Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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Retinal Ganglion Cell_DME
Identifier Type: -
Identifier Source: org_study_id
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