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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Federal University of São Paulo
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mauricio Maia, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT02055911
First received: February 3, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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


Condition Intervention Phase
Diabetic Macular Edema
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retinal Ganglion Cell Function After Repeated Intravitreous Ranibizumab in Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • The mean change in BCVA [ Time Frame: monthly, from baseline to Month 12 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • assess adverse events [ Time Frame: monthly, from Month 1 to Month 12 ] [ Designated as safety issue: Yes ]
    To assess adverse events during the twelve months of the study.


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).
Other Name: Lucentis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055911

Contacts
Contact: Eduardo Novais, MD 5521-98125-0506 eduardo@novais.md
Contact: Luci Silva, MBA 551155726443 luci.silva@unifesp.br

Locations
Brazil
Dept of Ophthalmology - UNIFESP/Hospital São Paulo Not yet recruiting
São Paulo, SP, Brazil, 04023-062
Contact: Cristina Muccioli, MD    551155726443    crissmucci@gmail.com   
Contact: Luci Silva, MBA    551155726443    luci.silva@unifesp.br   
Sub-Investigator: Eduardo Novais, MD         
Sub-Investigator: Emmerson Badaro, MD         
Sub-Investigator: Ricardo Japiassu, MD         
Sponsors and Collaborators
Federal University of São Paulo
Novartis
Investigators
Principal Investigator: Mauricio Maia, MD UNIFESP / HOSPITAL SÃO PAULO
  More Information

No publications provided

Responsible Party: Mauricio Maia, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02055911     History of Changes
Other Study ID Numbers: Retinal Ganglion Cell_DME
Study First Received: February 3, 2014
Last Updated: February 3, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
diabetic macular edema
intravitreal ranibizumab
f retinal ganglion cell

Additional relevant MeSH terms:
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014