Clinical trial NCT02800642: Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Retinal Vein Occlusion
Keywords: Bayer
Aflibercept
Eylea
Intravitreal
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 24 and Week 76
measure: The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks
timeFrame: From the last actual visit of the initiation phase to Week 76
Secondary outcomes:
measure: The Mean Treatment Interval Between Injections
timeFrame: From baseline to Week 76
measure: The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
timeFrame: Baseline and Week 24, 52, and 76
measure: The Change in Central Retinal Thickness (CRT) From Baseline
timeFrame: Baseline and Week 24, 52 and 76
measure: The Number of Injections Per Participant
timeFrame: From baseline to Week 76
measure: 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
timeFrame: Baseline and Week 24, Week 52
measure: The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
timeFrame: Baseline and Week 24, 52 and 76
measure: The Proportion of Participants With Absence of Subretinal Fluid
timeFrame: Baseline, week 24, week 52 and week 76
measure: Incidence and Severity of Ocular Treatment-emergent Adverse Events
timeFrame: Up to 30 days after week 76
Other outcomes:
Locations:
city: Albury
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Parramatta
country: Australia
city: Calgary
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Boisbriand
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Aalborg
country: Denmark
city: Glostrup
country: Denmark
city: Bordeaux
country: France
city: Dijon Cedex
country: France
city: Lyon
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Karlsruhe
country: Germany
state: Baden-Württemberg
city: Augsburg
country: Germany
state: Bayern
city: Göttingen
country: Germany
state: Niedersachsen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Hannover
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
state: Sachsen
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Pisa
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Oviedo
country: Spain
state: Asturias
city: Sant Cugat del Vallés
country: Spain
state: Barcelona
city: Viladecans
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Sunderland
country: United Kingdom
state: Tyne And Wear
city: Bradford
country: United Kingdom
state: West Yorkshire
city: Bristol
country: United Kingdom
city: Colchester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.