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

Central Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274259
• Other study ID #: 690110
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2020
• Source: St. Erik Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Sweden	St Eriks Eye Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Anders Kvanta

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of needed injections over a 18 month period comparing ranibizumab and aflibercept.		18 months
Secondary	Change in visual acuity	Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters	18 months
Secondary	Change in macular thickness	Change in macular thickness measured by Cirrus OCT (µm)	18 months