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

Phase 4

Completed

• Conditions: Central Retinal Vein Occlusion
• Interventions: Drug: Ranibizumab; Drug: Aflibercept

• Registration Number: NCT02274259
• Lead Sponsor: Anders Kvanta

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Primary Completion: 2015-06
• Study Completion: 2016-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The number of needed injections over a 18 month period comparing ranibizumab and aflibercept.	18 months

Secondary Outcome Measures

Name	Time	Method
Change in visual acuity	18 months	Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters
Change in macular thickness	18 months	Change in macular thickness measured by Cirrus OCT (µm)

Trial Locations

Locations (1)

St Eriks Eye Hospital; 🇸🇪 Stockholm, Sweden