check_circleStudy Completed

Central Retinal Vein Occlusion

Bayer Identifier:

17514

ClinicalTrials.gov Identifier:

NCT02800642

EudraCT Number:

2014-003193-17

EU CT Number:

Not Available
Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVO

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.


  • - 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.

Trial summary

Enrollment Goal
162
Trial Dates
June 2016 - July 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Boisbriand, J7H 1S6, Canada
Completed
Göttingen, 37075, Germany
Completed
Heidelberg, 69120, Germany
Completed
Köln, 50935, Germany
Completed
Münster, 48149, Germany
Completed
London, N6A 4V2, Canada
Completed
Sherbrooke, J1G 2V4, Canada
Completed
Hamilton, L8G 5E4, Canada
Completed
Roma, 00133, Italy
Completed
Ancona, 60126, Italy
Completed
Milano, 20132, Italy
Completed
Barcelona, 08024, Spain
Completed
Barcelona, 08025, Spain
Completed
Oviedo, 33012, Spain
Completed
Calgary, T2H 0C8, Canada
Completed
Augsburg, 86156, Germany
Completed
Bristol, BS1 2LX, United Kingdom
Completed
Colchester, CO3 3NB, United Kingdom
Completed
Freiburg, 79106, Germany
Completed
Düsseldorf, 40225, Germany
Completed
Sant Cugat del Vallés, 08195, Spain
Completed
Roma, 00198, Italy
Completed
Padova, 35128, Italy
Completed
Milano, 20157, Italy
Completed
Bradford, BD9 6RJ, United Kingdom
Completed
Liverpool, L9 7AL, United Kingdom
Completed
Pisa, 56124, Italy
Completed
Parramatta, 2150, Australia
Completed
Sydney, 2000, Australia
Completed
BORDEAUX, 33076, France
Completed
Dijon Cedex, BP 1542-21, France
Completed
LYON, 69004, France
Completed
Oxford, OX3 9DU, United Kingdom
Withdrawn
Taunton, TA1 5DA, United Kingdom
Completed
Glostrup, 2600, Denmark
Withdrawn
München, 81675, Germany
Completed
Aalborg, 9100, Denmark
Completed
Albury, 2640, Australia
Completed
Quebec, G1V 1T6, Canada
Completed
Leipzig, 04103, Germany
Completed
Hannover, 30625, Germany
Completed
Karlsruhe, 76133, Germany
Withdrawn
Düsseldorf, 40212, Germany
Withdrawn
Siegburg, 53721, Germany
Completed
Sunderland, SR2 9HP, United Kingdom
Withdrawn
London, NW1 5QH, United Kingdom
Completed
Viladecans, 08840, Spain
Withdrawn
Madrid, 28046, Spain

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    From the last actual visit of the initiation phase to Week 76

Secondary Outcome

  • The mean treatment interval between injections
    date_rangeTime Frame:
    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
    The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
    date_rangeTime Frame:
    Baseline and Week 24, 52, and 76
  • The change in central retinal thickness (CRT) from baseline
    CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
    date_rangeTime Frame:
    Baseline and Week 24, 52 and 76
  • The number of injections per participant
    date_rangeTime Frame:
    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
    The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
    date_rangeTime Frame:
    Baseline and Week 24, Week 52
  • The proportion of participants with change in retinal non-perfusion (FA/FP) status from baseline
    The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, <10 ischemic disc area, >=10 ischemic disc area and missing status
    date_rangeTime Frame:
    Baseline and Week 24, 52 and 76
  • The proportion of participants with absence of subretinal fluid
    date_rangeTime Frame:
    Baseline, week 24, week 52 and week 76
  • Incidence and severity of ocular treatment-emergent adverse events
    date_rangeTime Frame:
    Up to 30 days after week 76

Trial design

A multi-center, single-arm, interventional Phase 4 study to evaluate a Treat and Extend regimen of intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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