Clinical Trial: Ultra-wide Fluorescein Angiography in Patients With Central Retinal Vein Occlusion Treated by Afilbercept

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: Ultra-wide Fluorescein angiograpHy to Evaluate the Progression of Retinal ischeMia After aflibErcept Injections in patientS With Central Retinal Vein Occlusion in Real Lif

Brief Summary:

In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific.

With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.


Detailed Summary:

The pathophysiology of Central Retinal Vein Occlusion (CRVO) is incompletely understood, but a significant slow-down in blood flow, caused by various predisposing factors, results in the release of VEGF, leading to the breakdown of the blood-retinal-barrier and finally to macular edema. The level of VEGF has been also correlated with neovascularization and vascular permeability in patients with ischemic CRVO. Several treatments have been used to treat patients with CRVO such as hemodilution, surgery, laser treatment and corticoids injection. However anti-vascular endothelial growth factor (anti-VEGF) agents administered by intravitreal injection, improve both visual and anatomic outcomes in patients with macular edema secondary to CRVO. Aflibercept is a fusion protein, use by intravitreal injection. In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific. In these studies, anatomic outcomes such as ischemic progression and retinal perfusion status were evaluated as secondary objectives; the primary objective of these studies was visual outcome.

With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.


Sponsor: Centre Hospitalier Intercommunal Creteil

Current Primary Outcome: Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months [ Time Frame: Baseline and 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in visual acuity from baseline to months 3, 6, 12 and 24 [ Time Frame: Baseline and 3, 6, 12 and 24 months ]
  • Change from baseline in non-perfused areas in both macula and peripheral retina at 3, 6 and 12 months [ Time Frame: Baseline and 3, 6 and 12 months ]
  • Mean time between the last two injections [ Time Frame: Up to 18 weeks ]
  • Mean number of injections by patient from baseline to end-of-study visit [ Time Frame: From baseline to 24 months ]
  • Mean number of visits by patient from baseline to end-of-study visit [ Time Frame: From baseline to 24 months ]
  • Change from baseline in central retinal thickness at 3, 6, 12 and 24 months [ Time Frame: Baseline and 3, 6, 12 and 24 months ]
  • Change in vascular density in OCT-A from baseline to months 3, 6, 12, 24 [ Time Frame: Baseline and 3, 6, 12 and 24 months ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Intercommunal Creteil

Dates:
Date Received: August 23, 2016
Date Started: January 2017
Date Completion: January 2020
Last Updated: August 25, 2016
Last Verified: August 2016