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

NCT02800642 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 175142014-003193-17
• Study Type: interventional
• Target: 162
• Locations: 8 countries
• Sites: 42

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

Keywords

Bayer; Aflibercept; Eylea; Intravitreal

Outcome Measures

Primary Outcomes (2)

• The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline

  Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.

  Baseline, Week 24 and Week 76

• The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks

  Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema

  From the last actual visit of the initiation phase to Week 76

Secondary Outcomes (8)

• The Mean Treatment Interval Between Injections

  From baseline to Week 76

• The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline

  Baseline and Week 24, 52, and 76

• The Change in Central Retinal Thickness (CRT) From Baseline

  Baseline and Week 24, 52 and 76

• The Number of Injections Per Participant

  From baseline to Week 76

• The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline

  Baseline and Week 24, Week 52

Study Arms (1)

Intravitreal (IVT) aflibercept

EXPERIMENTAL

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

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321) 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.

Intravitreal (IVT) aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous PRP or macular laser photocoagulation in the study eye.
• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (42)

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Albury, New South Wales, 2640, Australia

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Sydney, New South Wales, 2000, Australia

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Parramatta, 2150, Australia

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Calgary, Alberta, T2H 0C8, Canada

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Hamilton, Ontario, L8G 5E4, Canada

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London, Ontario, N6A 4V2, Canada

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Boisbriand, Quebec, J7H 1S6, Canada

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Sherbrooke, Quebec, J1G 2V4, Canada

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Québec, G1V 1T6, Canada

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Aalborg, 9100, Denmark

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Glostrup Municipality, 2600, Denmark

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Bordeaux, 33076, France

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Dijon, BP 1542-21, France

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Lyon, 69004, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Karlsruhe, Baden-Wurttemberg, 76133, Germany

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Augsburg, Bavaria, 86156, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Cologne, North Rhine-Westphalia, 50935, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Hannover, North Rhine-Westphalia, 30625, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Leipzig, Saxony, 04103, Germany

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Rome, Lazio, 00133, Italy

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Rome, Lazio, 00198, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20157, Italy

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Ancona, The Marches, 60126, Italy

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Pisa, Tuscany, 56124, Italy

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Padua, Veneto, 35128, Italy

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Sant Cugat Del Vallés, Barcelona, 08195, Spain

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Viladecans, Barcelona, 08840, Spain

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Oviedo, Principality of Asturias, 33012, Spain

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Barcelona, 08024, Spain

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Barcelona, 08025, Spain

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Sunderland, Tyne and Wear, SR2 9HP, United Kingdom

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Bristol, BS1 2LX, United Kingdom

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Colchester, CO3 3NB, United Kingdom

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Liverpool, L9 7AL, United Kingdom

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Oxford, OX3 9DU, United Kingdom

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Related Publications (1)

• 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.

  PMID: 33556381 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 15, 2016
• Study Start: June 10, 2016
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: July 8, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-06

Locations

AU (3); GB (6); DE (10); ES (5); IT (7); FR (3); DK (2); CA (6)