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Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03709745
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital

Brief Summary:
Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO.

Condition or disease Intervention/treatment Phase
Branch Retinal Vein Occlusion With Macular Edema Drug: Aflibercept Injection [Eylea] Drug: Ranibizumab Injection [Lucentis] Phase 4

Detailed Description:

One hundred and ten patients with macular edema (ME) secondary to BRVO are randomized (1:1) to treatment with intravitreal injections of aflibercept or ranibizumab. An initial loading dose of at least three monthly injections is given in the study eye until the ME is resolved. Then patients are observed at regular intervals, initially every four weeks until study completion. Total follow-up time is nine months from baseline to completion. If ME recurs, patients are treated according to a treat-and-extend algorithm.

At every visit, visual acuity (VA) is measured with an ETDRS chart at 4 m. The fundus is examined by indirect ophthalmoscopy and by optical coherence tomography (OCT). Macular ischemia is evaluated with OCT angiography (OCT-A), visual field status with computerised perimetry and retinal sensitivity with microperimetry. Choroidal thickness is evaluated with enhanced depth imaging (EDI) OCT. Vision related quality of life (QoL) with NEI VFQ25.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Treatment With Aflibercept and Ranibizuamab for Macular Edema After Branch Retinal Vein Occlusion
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Aflibercept
Aflibercept is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given aflibercept according to a treat-and-extend regimen.
Drug: Aflibercept Injection [Eylea]
Intravitreal injection is given as described in the arm description
Other Name: Eylea

Active Comparator: Ranibizumab
Ranibizumab is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given ranibizumab according to a treat-and-extend regimen.
Drug: Ranibizumab Injection [Lucentis]
Intravitreal injection is given as described in the arm description
Other Name: Lucentis




Primary Outcome Measures :
  1. Difference in time to recurrence of macular edema [ Time Frame: 9 months ]
    Time, in weeks, from completion of loading dose to first recurrence of macular edema.


Secondary Outcome Measures :
  1. Comparison of the number of patients without ME in each treatment arm at one month after the first injection [ Time Frame: 1 month ]
    The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared

  2. Comparison of the number of injections needed in each treatment arm to resolve ME [ Time Frame: 9 months ]
    The number of injections needed for macular edema to resolve in each treatment arm are compared

  3. Occurrence and evolution of macular ischemia over time [ Time Frame: 9 moths ]
    Area of non perfusion measured by OCT-angiography

  4. Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs. [ Time Frame: 9 months ]
  5. Correlation of vision related QoL in patients with a good visual acuity and findings on visual fields, retinal sensitivity, macular ischemia and near VA. [ Time Frame: 9 months ]


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:

  • BRVO naïve patients, disease duration 1-6 months, BCVA 23-73 ETDRS letters (20/40-20/320), macula edema with intraretinal cysts and CRT > 300 micrometers (Cirrus)

Exclusion Criteria:

  • BRVO with neovascular component, intraocular surgery during the previous 3 months, earlier vitreoretinal surgery, vascular retinopathy of other cause, intraocular infection/inflammation, myocardial infarction och cerebrovascular 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): NCT03709745


Contacts
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Contact: Manuel Casselholm de Salles, MD +4686723000 manuel.casselholm-desalles@sll.se

Sponsors and Collaborators
St. Erik Eye Hospital
Investigators
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Principal Investigator: Anders Kvanta, MD PhD St. Erik Eye Hospital
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Responsible Party: Anders Kvanta, Principal investigator, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT03709745    
Other Study ID Numbers: 2017/2422-31
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents