Treatment of Diabetic macular edema with intravitreal injection of antiangiogenic agents with or without Dexamethasone

Phase 2

• Conditions: Macular Edema; Diabetes; C19.246.099

• Registration Number: RBR-7468j4q
• Lead Sponsor: niversidade Federal de Pernambuco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-15
• Last Update Posted: 26 June 2023
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age equal to or greater than 18 years; both genders; diagnosis of diabetes; presence of clinically significant diabetic macular edema in at least one eye according to the ETDRS (Early Treatment Diabetic Retinopathy Study) guidelines; Best Corrected Visual Acuity between 20/400 and 20/40; Central Macular Thickness >= 300 µm, measured by Spectral Domain Optical Coherence Tomography

Exclusion Criteria

Any diabetic macular edema treatment in the last 4 months; Panretinal photocoagulation in the last 4 months; any eye surgery performed in the last 4 months; history of Pars Plana Vitrectomy; hx of open-angle glaucoma or corticosteroid-induced elevated intraocular pressure requiring ocular antiglaucoma or antihypertensive treatment; intraocular pressure >= 21 mmHg; history of allergy to any product used in the procedure; presence of tractional retinal detachment

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the corrected visual acuity of volunteers undergoing treatment for diabetic macular edema with intravitreal injection of anti-VEGF agents associated or not with a 4 mg/mL dexamethasone solution 90 days after the first intravitreal injection. Subjects treated with dexamethasone are expected to do at least 10% better than untreated subjects;To evaluate the macular thickness, through optical coherence tomography, of volunteers undergoing treatment for diabetic macular edema with intravitreal injection of anti-VEGF agents associated or not with a 4 mg/mL dexamethasone solution 90 days after the first intravitreal injection. Subjects treated with dexamethasone are expected to do at least 10% better than untreated subjects