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OpenTrials
Completed

NCT Number: NCT02274259

Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen

Comparing ranibizumab and aflibercept in a treat and extend algorithm evaluating the number of needed injections over a 18 month period in patients with newly diagnosed CRVO.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Eriks Eye Hospital

Stockholm, 11282, Sweden

About this study

Forty patients diagnosed with a new central retinal vein occlusion (CRVO) of a maximum duration of 6 months will be recruited to the study. Patients will be randomized 1:1 to treatment with aflibercept ot ranibizumab.

all patients will receive 3 initial monthly injections. There after injections will be given att every visit according to a treat and extend schedule. If no macular edema is seen on the Ocular coherent tomography (OCT) examination the next treatment will be after 6 weeks. If the macula is dry after 6 weeks a new injection is given and the next visit is scheduled for another 8 weeks. If edema is seen on the OCT after 8 weeks the time to next injection is reduced to 6 weeks. Patients cannot receive an injection more often than every 4 weeks. All patients will receive an injection at least every 12 weeks.

Primary outcome: the number of needed injections over a 18 month period comparing ranibizumab and aflibercept.

Secondary outcome: Change in visual acuity, change in macular thickness. A subgroup of patients will also be evaluated with OCT angiography. A possible relationship between the Visual acuity and the foveal avascular zone will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • CRVO - naive patients, disease duration maximum 12 months, Best corrected visual acuity : 23-73 letters (20/40 - 20/320), Macular edema > 300 μm (Cirrus)

Exclusion criteria

  • Neovascular Glaucoma Any previous treatment for CRVO. Intraocular surgery during the previous 3 months. Vascular retinopathy of other causes. Glaucoma with uncontrolled IOP (intra ocular pressure) Myocardial infarction or stroke during the last 3 months.

Treatment and study plan

aflibercept

Drug

Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema

Other names: Eylea

ranibizumab

Drug

Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema

Other names: Lucentis

Primary outcomes

  1. The number of needed injections over a 18 month period comparing ranibizumab and aflibercept.

    Time frame: 18 months

Secondary outcomes

  1. Change in visual acuity

    Time frame: 18 months

    Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters

  2. Change in macular thickness

    Time frame: 18 months

    Change in macular thickness measured by Cirrus OCT (µm)

Sponsors and collaborators

Lead sponsor

Anders Kvanta

Other

Registry information

Official study title

Randomized Trial Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With Central Retinal Vein Occlusion With a Treat and Extend Algorithm

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 24, 2014
Registry last updated
Dec 4, 2020

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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