drugset / Trial / NCT05861466

Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A

NCT05861466

Phase 4 Completed 102 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindSupportive care

Summary

The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present . The main question\[s\]it aims to answer are: •\[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?\] •\[is there any effect of Prior Anterior Chamber Paracentesis?\] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)\& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . \]

Timeline

Start
2023-01-01
Primary completion
2024-11-24
Completion
2024-11-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal