Actively Recruiting
Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity Structural Outcome
Led by Asociación para Evitar la Ceguera en México · Updated on 2024-07-31
N/A
Participants Needed
1
Research Sites
904 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Retinopathy of prematurity (ROP) is a serious condition that can cause blindness in children. This trial evaluates the safety and effectiveness of using intravitreal bevacizumab, a drug that blocks vascular endothelial growth factor (VEGF), to treat ROP. VEGF plays a key role in the abnormal blood vessel growth seen in ROP, and this study aims to prevent harmful neovascularization by inhibiting VEGF during the disease's active phase. Participants receive intravitreal injections of bevacizumab directly into the eye. The study focuses on babies with advanced stages of ROP (stages III, IV, and V) who cannot be treated with laser therapy or cryotherapy. This non-randomized trial monitors the structural outcomes of the eye after treatment to assess the drug's effect on disease progression. During the study, researchers will evaluate the clinical appearance of the eye to measure treatment effects. The trial includes regular eye examinations to monitor safety and response. Participation lasts from the time of treatment until the final assessment of eye structure, with the study ending in November 2024. Safety and structural changes in the retina form the primary focus of the assessments.
CONDITIONS
Brief Title
Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Retinopathy of prematurity stages III, IV, or V
- Condition unsuitable for treatment with laser therapy or cryotherapy
- Age between 1 and 12 months
You will not qualify if you...
- Patients who can be treated with cryotherapy or laser therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive intravitreal injection as active treatment for retinopathy of prematurity.
Trial Site Locations
Total: 1 location
1
Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes"
Mexico City, Mexico DF, Mexico, 04030
Actively Recruiting
Research Team
H
Hugo Quiroz-Mercado, MD
M
Maria A Martínez-Castellanos, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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