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

ID: NCT02274259
Status: Active, not recruiting
Phase: Phase 4
Start Date: October 01, 2014
First Submitted: October 02, 2014
Last Updated: November 23, 2016
Results: N/A
Organization: St. Erik Eye Hospital
Sponsors & Collaborators: Anders Kvanta
Location: Sweden
Conditions: Central Retinal Vein Occlusion
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Study Description

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.
Condition or disease Intervention/treatment Phase

Central Retinal Vein Occlusion

Drug: Aflibercept
Other Names
Eylea
Drug: Ranibizumab
Other Names
Lucentis
Phase 4

Tracking Information

First Submitted DateOctober 02, 2014
Last Update Posted DateNovember 23, 2016
Start DateOctober 01, 2014
Anticipated Completion DateDecember 01, 2016
Primary Completion DateJune 01, 2015
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • The number of needed injections over a 18 month period comparing ranibizumab and aflibercept. [Time Frame: 18 months]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Change in visual acuity [Time Frame: 18 months]

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

  • Change in macular thickness [Time Frame: 18 months]

    Change in macular thickness measured by Cirrus OCT (µm)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen
Official TitleRandomized Trial Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With Central Retinal Vein Occlusion With a Treat and Extend Algorithm
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 TypeInterventional
Study PhasePhase 4
Estimated Enrollment
40
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Central Retinal Vein Occlusion
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Aflibercept

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

Other Names
Eylea
Drug: Ranibizumab

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

Other Names
Lucentis
Study Groups/Cohorts
Aflibercept
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema

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

Study Arms
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

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

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

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment40
Completion DateDecember 01, 2016
Eligibility Criteria: 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Sweden

Administrative Information

NCT Number:NCT02274259
Other Study ID Numbers
690110
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyAnders Kvanta, St. Erik Eye Hospital
Study Sponsor
Anders Kvanta
Collaborators
Not Available
Investigators
Study Chair
Sofie Westman
Study coordinator