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Trial record 24 of 81 for:    CRVO - Central Retinal Vein Occlusion

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

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ClinicalTrials.gov Identifier: NCT02274259
Recruitment Status : Unknown
Verified November 2016 by Anders Kvanta, St. Erik Eye Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 24, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital

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.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: Aflibercept Drug: Ranibizumab Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With Central Retinal Vein Occlusion With a Treat and Extend Algorithm
Study Start Date : October 2014
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Lucentis




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

Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274259


Locations
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Sweden
St Eriks Eye Hospital
Stockholm, Sweden, 11282
Sponsors and Collaborators
Anders Kvanta
Investigators
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Study Chair: Sofie Westman Study coordinator

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anders Kvanta, Principal investigator, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT02274259     History of Changes
Other Study ID Numbers: 690110
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Venous Thrombosis
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents