Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO

NCT ID: NCT02800642

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-10
• Study Completion Date: 2019-07-31

Brief Summary

Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries.

The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.

Conditions

Central Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravitreal (IVT) aflibercept

Participants with macular edema secondary to CRVO were treated with the study drug intravitreal aflibercept

Group Type: EXPERIMENTAL

Aflibercept (Eylea, BAY86-5321)

Intervention Type: DRUG

The recommended dose for intravitreal aflibercept was 2 mg equivalent to 50 μL. Study treatment was administered at baseline and at monthly intervals until stabilization of disease. When stability was achieved, the treatment interval could be extended based on visual and anatomic outcomes as judged by the treating investigator.

Interventions

Aflibercept (Eylea, BAY86-5321)

The recommended dose for intravitreal aflibercept was 2 mg equivalent to 50 μL. Study treatment was administered at baseline and at monthly intervals until stabilization of disease. When stability was achieved, the treatment interval could be extended based on visual and anatomic outcomes as judged by the treating investigator.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).
• Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's routine treatment practice with the intent to use a T&E regimen after initial dosing.
• Treatment-naïve subjects for macular edema secondary to CRVO.
• Men and women ≥ 18 years of age.
• Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye.

Exclusion Criteria

• Previous PRP or macular laser photocoagulation in the study eye.
• Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
• Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
• Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
• Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
• Any history of allergy to povidone iodine.
• Known serious allergy to the fluorescein sodium for injection in angiography.
• Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Karlsruhe, Baden-Wurttemberg, Germany

Augsburg, Bavaria, Germany

Göttingen, Lower Saxony, Germany

Cologne, North Rhine-Westphalia, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Hannover, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Leipzig, Saxony, Germany

Rome, Lazio, Italy

Rome, Lazio, Italy

Milan, Lombardy, Italy

Milan, Lombardy, Italy

Ancona, The Marches, Italy

Pisa, Tuscany, Italy

Padua, Veneto, Italy

Sant Cugat Del Vallés, Barcelona, Spain

Viladecans, Barcelona, Spain

Oviedo, Principality of Asturias, Spain

Barcelona, , Spain

Barcelona, , Spain

Sunderland, Tyne and Wear, United Kingdom

Bradford, West Yorkshire, United Kingdom

Bristol, , United Kingdom

Colchester, , United Kingdom

Liverpool, , United Kingdom

Oxford, , United Kingdom

Albury, New South Wales, Australia

Sydney, New South Wales, Australia

Parramatta, , Australia

Calgary, Alberta, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Boisbriand, Quebec, Canada

Sherbrooke, Quebec, Canada

Québec, , Canada

Aalborg, , Denmark

Glostrup Municipality, , Denmark

Bordeaux, , France

Dijon, , France

Lyon, , France

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Heidelberg, Baden-Wurttemberg, Germany

Countries

Australia; Canada; Denmark; France; Germany; Italy; Spain; United Kingdom

References

Korobelnik JF, Larsen M, Eter N, Bailey C, Wolf S, Schmelter T, Allmeier H, Chaudhary V. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study. Am J Ophthalmol. 2021 Jul;227:106-115. doi: 10.1016/j.ajo.2021.01.027. Epub 2021 Feb 6.

Reference Type: DERIVED

PMID: 33556381 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2014-003193-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17514

Identifier Type: -

Identifier Source: org_study_id