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Clinical Trials
QUASAR
A Randomized, Double-Masked, Active-Controlled, Phase 3 Study Of The Efficacy And Safety Of Aflibercept 8 Mg In Macular Edema Secondary To Retinal Vein Occlusion.
Overview
This is a Phase-3, multi-center, randomized, double-masked, active-controlled clinical study to assess the efficacy and safety of high dose (8 mg) aflibercept administered IVT compared to 2 mg aflibercept treatment in participants with treatment-naïve macular edema secondary to Retinal Vein Occlusion (RVO).
An RVO occurs when a blood vessel (vein) that carries blood away from the retina becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the centre of the retina responsible for fine vision). This swelling is called macular oedema and may cause the vision to become blurry.
Aflibercept is approved in Australia for the treatment of macular oedema secondary to RVO (among other conditions). However, in this study it will be administered at a higher dose, which has not been approved. This means that it is an experimental treatment in this study.
This study will assess the efficacy and safety of a high dose of aflibercept for the treatment of macular oedema secondary to RVO and aims to better understand the studied disease and associated health problems. The study duration is 16 months and participants will be required to attend 18 study visits.
- Principal Investigator
Associate Professor Sanj Wickremasinghe
This is a Phase-3, multi-center, randomized, double-masked, active-controlled clinical study to assess the efficacy and safety of high dose (8 mg) aflibercept administered IVT compared to 2 mg aflibercept treatment in participants with treatment-naïve macular edema secondary to Retinal Vein Occlusion (RVO).
An RVO occurs when a blood vessel (vein) that carries blood away from the retina becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the centre of the retina responsible for fine vision). This swelling is called macular oedema and may cause the vision to become blurry.
Aflibercept is approved in Australia for the treatment of macular oedema secondary to RVO (among other conditions). However, in this study it will be administered at a higher dose, which has not been approved. This means that it is an experimental treatment in this study.
This study will assess the efficacy and safety of a high dose of aflibercept for the treatment of macular oedema secondary to RVO and aims to better understand the studied disease and associated health problems. The study duration is 16 months and participants will be required to attend 18 study visits.
- Principal Investigator
Learn more
View this study at ClinicalTrials.gov
This international database listing provides more detailed information about this study.