Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02055911
Recruitment Status : Withdrawn
First Posted : February 5, 2014
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mauricio Maia, Federal University of São Paulo

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ranibizumab Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : March 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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:
  1. assess adverse events [ Time Frame: monthly, from Month 1 to Month 12 ]
    To assess adverse events during the twelve months of the study.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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


Locations
Layout table for location information
Brazil
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Novartis
Investigators
Layout table for investigator information
Principal Investigator: Mauricio Maia, MD UNIFESP / HOSPITAL SÃO PAULO

Layout table for additonal information
Responsible Party: Mauricio Maia, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02055911    
Other Study ID Numbers: Retinal Ganglion Cell_DME
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 22, 2018
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:
Layout table for MeSH terms
Ganglion Cysts
Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents