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

NCT02308644 | Completed Phase 3 DMC

• 1 other identifier: 80838792A
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Retinopathy; intravitreal bevacizumab; Contrast Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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

  6 months (24 weeks )

Secondary Outcomes (1)

• Metabolic control

  6 months (24 weeks)

Study Arms (2)

Bevacizumab

EXPERIMENTAL

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)

Sham

SHAM COMPARATOR

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)

Interventions

intravitreal bevacizumab injection(1.25mg) DRUG

intravitreal bevacizumab injection(1.25mg) / Sham injection

Also known as: Avastin, Genentech Inc., South San Francisco, CA, EUA

Bevacizumab; Sham

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30763599 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Bevacizumab; Emergency Use Authorization

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Legislation, Medical; Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations

Study Officials

• AUGUSTO MOTTA

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intravitreous Bevacizumab and standard metabolic control for Diabetic Macular Edema - A Contrast Sensitivity Study.

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 4, 2014
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2013
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

BR (1)