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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
intravitreal bevacizumab injection(1.25mg)
Sponsored by
University of Sao 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 Retinopathy, intravitreal bevacizumab, Contrast Sensitivity

Eligibility Criteria

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

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;

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Bevacizumab

Sham

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Contrast sensitivity
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

Secondary Outcome Measures

Metabolic control
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%).

Full Information

First Posted
November 24, 2014
Last Updated
December 1, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02308644
Brief Title
Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Study
Official Title
Phase 3 Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Retinopathy, intravitreal bevacizumab, Contrast Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
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)
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
intravitreal bevacizumab injection(1.25mg)
Other Intervention Name(s)
Avastin, Genentech Inc., South San Francisco, CA, EUA
Intervention Description
intravitreal bevacizumab injection(1.25mg) / Sham injection
Primary Outcome Measure Information:
Title
Contrast sensitivity
Description
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
Time Frame
6 months (24 weeks )
Secondary Outcome Measure Information:
Title
Metabolic control
Description
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%).
Time Frame
6 months (24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AUGUSTO MOTTA
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30763599
Citation
Motta AAL, Bonanomi MTBC, Ferraz DA, Preti RC, Sophie R, Abalem MF, Queiroz MS, Pimentel SLG, Takahashi WY, Damico FM. Short-term effects of intravitreal bevacizumab in contrast sensitivity of patients with diabetic macular edema and optimizing glycemic control. Diabetes Res Clin Pract. 2019 Mar;149:170-178. doi: 10.1016/j.diabres.2019.02.002. Epub 2019 Feb 11.
Results Reference
derived

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

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