Clinical trial NCT02308644: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: Diabetic Retinopathy
intravitreal bevacizumab
Contrast Sensitivity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Contrast sensitivity
timeFrame: 6 months (24 weeks )
Secondary outcomes:
measure: Metabolic control
timeFrame: 6 months (24 weeks)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: AUGUSTO MOTTA
role: PRINCIPAL_INVESTIGATOR
References:
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.