Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Study

December 1, 2014 updated by: Augusto Alves Lopes da Motta, University of Sao Paulo

Phase 3 Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Pilot Study.

To evaluate the effects on contrast sensitivity (CS) measurements of intravitreal bevacizumab injections associated with standard metabolic control in eyes with diabetic macular edema (DME) associated with standard metabolic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized, masked and interventional study. Patients with diabetes mellitus (DM) 2, glycated hemoglobin (HbA1c) less than 11% and previously treated macular edema three months before will be randomized in two groups. The baseline examination consisted of visual acuity (VA), CS using the Pelli-Robson Charts, optical coherence tomography (OCT) and Fluorescein Angiography for all eyes.

The same tests will be repeated above, in both groups, again, in the week 2,6 and 12, when the data is then collected for analysis and so ended the closed phase. On the same day will start the open phase, which will be applied intravitreal injection of bevacizumab in both groups and the same tests of closed phase will be held in the week 14,18 and 24 when the study will be completed then [Table 1] .

Patients will be monitored and controlled clinically including blood pressure measurements, laboratory blood tests such as blood glucose, glycated hemoglobin, urea, creatinine, total cholesterol and fractions.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age at least 18 years old, of both genders;
  • Patients with diabetes mellitus type I or type II;
  • Macular edema presence of clinically significant diabetic in their mixed or diffuse;
  • Visual acuity worse than 20/40 corrected (< 68 letters ETDRS)
  • Glycated hemoglobin ≤ 11%;
  • Systolic and diastolic blood pressure < 170 and < 100 mmHg, respectively;
  • Women not pregnant;
  • Free and informed consent term signed the screening visit;
  • Ability to adhere to the visits.

Exclusion Criteria:

  • Failure to comply with any of the inclusion criteria;
  • Treatment for DME within the prior 3 months;
  • Vitreoretinal traction within 1 disc diameter (DD) of the fovea, clinically confirmed or with OCT;
  • Atrophy or fibrosis surrounding the fovea;
  • Any level of cataract;
  • Vitreous hemorrhage or any opacity means;
  • Eye disease related to diabetic retinopathy that can derail the central vision (eg Age Macula Degeneration, chorioretinitis scar, ...)
  • Best-corrected visual acuity to 20/40 (> 68 letters ETDRS)
  • Inability to understand the treatment and the term of consent;
  • Debilitating systemic disorders that preclude the patient's admission to the study, according to the clinical judgment of the investigator;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
Group 1 - 21 eyes treated with intravitreal bevacizumab injection (1.25mg) at the weeks 0, 6,12 and 18 plus standard metabolic control with glycated hemoglobin measured at baseline, week 12 and 18. All patients were followed by expert (endocrinologist)
Drug: intravitreal bevacizumab injection(1.25mg)
intravitreal bevacizumab injection(1.25mg) / Sham injection
Other Names:
  • Avastin, Genentech Inc., South San Francisco, CA, EUA
Sham Comparator: Sham
Group 2 - 20 eyes treated with sham injection at weeks 0 and 6; and intravitreal bevacizumab injection(1.25mg) in the weeks 12 and 18 plus standard metabolic control with glycated hemoglobin measured at baseline, week 12 and 18. All patients were followed by expert (endocrinologist)
Drug: intravitreal bevacizumab injection(1.25mg)
intravitreal bevacizumab injection(1.25mg) / Sham injection
Other Names:
  • Avastin, Genentech Inc., South San Francisco, CA, EUA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast sensitivity
Time Frame: 6 months (24 weeks )
Evaluate the Contrast Sensitivity measured by Pelli-Robson charts (Clement Clarke Inc., Columbus, OH) at baseline, weeks 2,6,12,14,18 and 24 to be compared with visual acuity gold standard - Early Treatment of Diabetic Retinopathy Study - ETDRS charts
6 months (24 weeks )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic control
Time Frame: 6 months (24 weeks)
Evaluate the effects of the standard metabolic control with glycated hemoglobin (HbA1c) levels in eyes with diabetic macular edema, measured by method certified by National Glycohemoglobin Standardization Program (NGSP) / reference values = 4.1 a 6.5%).
6 months (24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: AUGUSTO MOTTA, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80838792A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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