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

NCT ID: NCT02308644

Last Updated: 2014-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-02-28

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

intravitreal bevacizumab injection(1.25mg)

Intervention Type: DRUG

intravitreal bevacizumab injection(1.25mg) / Sham injection

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)

Group Type: SHAM_COMPARATOR

intravitreal bevacizumab injection(1.25mg)

Intervention Type: DRUG

intravitreal bevacizumab injection(1.25mg) / Sham injection

Interventions

intravitreal bevacizumab injection(1.25mg)

intravitreal bevacizumab injection(1.25mg) / Sham injection

Intervention Type: DRUG

Other Intervention Names

Avastin, Genentech Inc., South San Francisco, CA, EUA

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.

• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Augusto Alves Lopes da Motta

Intravitreous Bevacizumab and standard metabolic control for Diabetic Macular Edema - A Contrast Sensitivity Study.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AUGUSTO MOTTA

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 30763599 (View on PubMed)

Other Identifiers

80838792A

Identifier Type: -

Identifier Source: org_study_id