Diabetic Macular Edema
Conditions
Keywords
diabetic macular edema, intravitreal ranibizumab, f retinal ganglion cell
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.
Interventions
DRUGRanibizumab
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).
Sponsors
Novartis
Federal University of São Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV) | at Baseline and Months 3, 6, 9, 12 | The photopic negative response (PhNR) of the full-field cone electroretinograms (ERGs) is a functional indicator of retinal ganglion. The PhNR consists of a negative-going wave that follows the photopic cone b wave. The PhNR is selectively attenuated in patients with optic nerve disease and glaucoma, indicating that the PhNR can be an objective functional measure reflecting the sum of the total response of the retinal ganglion cells in the entire retina. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mean change in BCVA | monthly, from baseline to Month 12 | The mean change in best corrected visual acuity (BCVA) from baseline to month 12 |
| the mean change in central macular thickness (CMT) | monthly, from baseline to Month 12 | To assess the mean change in central macular thickness (CMT), measured in spectral-domain optical coherence tomography (SD-OCT) from baseline to month 12 |
Other
| Measure | Time frame | Description |
|---|---|---|
| assess adverse events | monthly, from Month 1 to Month 12 | To assess adverse events during the twelve months of the study. |
Countries
Brazil
Outcome results
None listed