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

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

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.

Study Overview

• Status: Completed
• Conditions: Central Retinal Vein Occlusion
• Intervention / Treatment: Drug: Aflibercept; Drug: Ranibizumab

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11282
    • St Eriks Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aflibercept; Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema	Drug: Aflibercept; Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema; Other Names: Eylea
Active Comparator: Ranibizumab; Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema	Drug: Ranibizumab; Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of needed injections over a 18 month period comparing ranibizumab and aflibercept.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual acuity	Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters	18 months
Change in macular thickness	Change in macular thickness measured by Cirrus OCT (µm)	18 months

Collaborators and Investigators

• Sponsor: Anders Kvanta
• Investigators: Study Chair: Sofie Westman, study coordinator

Publications and helpful links

General Publications

• Casselholmde Salles M, Kvanta A, Amren U, Epstein D. Optical Coherence Tomography Angiography in Central Retinal Vein Occlusion: Correlation Between the Foveal Avascular Zone and Visual Acuity. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT242-6. doi: 10.1167/iovs.15-18819.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Aflibercept
• Other Study ID Numbers: 690110