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OpenTrials
Completed

NCT Number: NCT06416241

Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion

Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion.

Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials.

The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Thrombosis Vascular Diseases Vascular Occlusive Disease Venous Thrombosis

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months.
  • Patients >18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions
  • BCVA of Snellen of 20/40 to 20/200 in the study eye

Exclusion criteria

  • Previous PRP or macular laser photocoagulation in the study eye.
  • Any prior ocular treatment in the study eye for macular edema secondary to CRVO.
  • Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study.
  • Any active or previous inflammation, ocular trauma
  • Uncontrolled glaucoma (IOP>30 mmHg)

Treatment and study plan

EYLEA 2 MG in 0.05 ML Injection

Drug

Intravitreal injection

Primary outcomes

  1. Change in visual acuity as measured using ETDRS charts

    Time frame: 5 years

  2. Change in retinal thickness as measured in μm using spectral domain optical coherence tomography

    Time frame: 5 years

Secondary outcomes

  1. Change in microvascular parameters in OCT angiography (vessel density, FAZ area)

    Time frame: 2 years

  2. Complications

    Time frame: 5 years

  3. Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Acronym: INTRAMED-CRVO

Important dates

Study start
2017
Primary completion
2020
Study completion
2024
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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