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

Primary Purpose

Diabetic Macular Edema

Status
Withdrawn
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring diabetic macular edema, intravitreal ranibizumab, f retinal ganglion cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept of Ophthalmology - UNIFESP/Hospital São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The mean change in BCVA
The mean change in best corrected visual acuity (BCVA) from baseline to month 12
the mean change in central macular thickness (CMT)
To assess the mean change in central macular thickness (CMT), measured in spectral-domain optical coherence tomography (SD-OCT) from baseline to month 12

Full Information

First Posted
February 3, 2014
Last Updated
August 21, 2018
Sponsor
Federal University of São Paulo
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02055911
Brief Title
Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema
Official Title
Retinal Ganglion Cell Function After Repeated Intravitreous Ranibizumab in Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
diabetic macular edema, intravitreal ranibizumab, f retinal ganglion cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
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).
Primary Outcome Measure Information:
Title
focal macular changes in full-field and photopic negative response (PhRN) amplitude (in µV)
Description
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.
Time Frame
at Baseline and Months 3, 6, 9, 12
Secondary Outcome Measure Information:
Title
The mean change in BCVA
Description
The mean change in best corrected visual acuity (BCVA) from baseline to month 12
Time Frame
monthly, from baseline to Month 12
Title
the mean change in central macular thickness (CMT)
Description
To assess the mean change in central macular thickness (CMT), measured in spectral-domain optical coherence tomography (SD-OCT) from baseline to month 12
Time Frame
monthly, from baseline to Month 12
Other Pre-specified Outcome Measures:
Title
assess adverse events
Description
To assess adverse events during the twelve months of the study.
Time Frame
monthly, from Month 1 to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Maia, MD
Organizational Affiliation
UNIFESP / HOSPITAL SÃO PAULO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

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

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