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

NCT02055911 | Withdrawn Phase 4 DMC

• 1 other identifier: Retinal Ganglion Cell_DME
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema; intravitreal ranibizumab; f retinal ganglion cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The mean change in BCVA

  monthly, from baseline to Month 12

• the mean change in central macular thickness (CMT)

  monthly, from baseline to Month 12

Other Outcomes (1)

• assess adverse events

  monthly, from Month 1 to Month 12

Study Arms (1)

Ranibizumab

EXPERIMENTAL

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

Interventions

Ranibizumab DRUG

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).

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Novartis: collaborator

Study Sites (1)

Dept of Ophthalmology - UNIFESP/Hospital São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mauricio Maia, MD

  UNIFESP / HOSPITAL SÃO PAULO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 5, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 22, 2018

Record last verified: 2014-02

Locations

BR (1)