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

Overview

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

Full Title of Study: “Retinal Ganglion Cell Function After Repeated Intravitreous Ranibizumab in Diabetic Macular Edema”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

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

  • 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).

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV)
    • Time Frame: 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 Measures

  • The mean change in BCVA
    • Time Frame: 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)
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mauricio Maia, Professor – Federal University of São Paulo
  • Overall Official(s)
    • Mauricio Maia, MD, Principal Investigator, UNIFESP / HOSPITAL SÃO PAULO

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.