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

Diabetic Macular Edema Clinical Trial

Official title:

Retinal Ganglion Cell Function After Repeated Intravitreous Ranibizumab in Diabetic Macular Edema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02055911
• Other study ID #: Retinal Ganglion Cell_DME
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Ganglion Cysts
• Macular Edema

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Brazil	Dept of Ophthalmology - UNIFESP/Hospital São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	assess adverse events	To assess adverse events during the twelve months of the study.	monthly, from Month 1 to Month 12
Primary	focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV)	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.	at Baseline and Months 3, 6, 9, 12
Secondary	The mean change in BCVA	The mean change in best corrected visual acuity (BCVA) from baseline to month 12	monthly, from baseline to Month 12
Secondary	the mean change in central macular thickness (CMT)	To assess the mean change in central macular thickness (CMT), measured in spectral-domain optical coherence tomography (SD-OCT) from baseline to month 12	monthly, from baseline to Month 12