We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Mauricio Maia, Federal University of São Paulo.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02055911
First Posted: February 5, 2014
Last Update Posted: February 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Mauricio Maia, Federal University of São Paulo
  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: Intervention Model: Single Group Assignment
Masking: None (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 Mauricio Maia, 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 ]
    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 ]
    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


Other Outcome Measures:
  • assess adverse events [ Time Frame: monthly, from Month 1 to Month 12 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 3, 2014
First Posted: February 5, 2014
Last Update Posted: February 5, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Edema
Macular Edema
Ganglion Cysts
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents