Clinical trial NCT01012973: Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Official title: A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinal Vein Occlusion
Keywords: Macular Edema
Central Retinal Vein Occlusion
CRVO
VEGF Trap-Eye
best-corrected visual acuity
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2009-11-13
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion


Eligibility criteria: Inclusion Criteria:

* Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (OCT)
* Adults ≥ 18 years
* Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion Criteria:

* Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
* Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
* CRVO disease duration \> 9 months from date of diagnosis
* Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
* Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Primary outcomes:
measure: Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
timeFrame: Baseline and Week 24
measure: Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Developed Neovascularization During the First 24 Weeks
timeFrame: From baseline until Week 24
measure: Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF
timeFrame: Baseline and Week 24
measure: Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Chatswood
country: Australia
state: New South Wales
city: Parramatta
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: East Melbourne
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Paris
country: France
state: Cedex 12
city: Nantes
country: France
state: Cedex 1
city: Bordeaux
country: France
city: Dijon
country: France
city: Marseille
country: France
city: Paris
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Darmstadt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Göttingen
country: Germany
state: Niedersachsen
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Chemnitz
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Ancona
country: Italy
city: Bari
country: Italy
city: Catania
country: Italy
city: Firenze
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Urayasu
country: Japan
state: Chiba
city: Suita
country: Japan
state: Osaka
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Kyoto
country: Japan
city: Seongnam-si
country: Korea, Republic of
state: Gyeonggido
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Singapore
country: Singapore
city: Singapore
country: Singapore
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Holz FG, Roider J, Ogura Y, Korobelnik JF, Simader C, Groetzbach G, Vitti R, Berliner AJ, Hiemeyer F, Beckmann K, Zeitz O, Sandbrink R. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Mar;97(3):278-84. doi: 10.1136/bjophthalmol-2012-301504. Epub 2013 Jan 7.
citation: Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology. 2014 Jan;121(1):202-208. doi: 10.1016/j.ophtha.2013.08.012. Epub 2013 Sep 29.