Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

NCT01012973 | Completed Phase 3 Results DMC

• 2 other identifiers: 141302009-010973-19
• Study Type: interventional
• Target: 177
• Locations: 9 countries
• Sites: 67

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

Conditions

Retinal Vein Occlusion

Keywords

Macular Edema; Central Retinal Vein Occlusion; CRVO; VEGF Trap-Eye; best-corrected visual acuity

Outcome Measures

Primary Outcomes (1)

• 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

  Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.

  Baseline and Week 24

Secondary Outcomes (5)

• Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)

  Baseline and Week 24

• Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF

  Baseline and Week 24

• Percentage of Participants Who Developed Neovascularization During the First 24 Weeks

  From baseline until Week 24

• Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF

  Baseline and Week 24

• Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF

  Baseline and Week 24

Study Arms (2)

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

EXPERIMENTAL

Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321); Other: Sham treatment

Sham treatment

SHAM COMPARATOR

Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.

Other: Sham treatment

Interventions

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) BIOLOGICAL

Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Sham treatment OTHER

Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321); Sham treatment

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (73)

Unknown Facility

Chatswood, New South Wales, 2067, Australia

Location

Unknown Facility

Parramatta, New South Wales, 2150, Australia

Location

Unknown Facility

Sydney, New South Wales, 2000, Australia

Location

Unknown Facility

Westmead, New South Wales, 2145, Australia

Location

Unknown Facility

East Melbourne, Victoria, 3002, Australia

Location

Unknown Facility

Nedlands, Western Australia, 6009, Australia

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Linz, 4021, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Paris, Cedex 12, 75557, France

Location

Unknown Facility

Nantes, Cedex 1, 44093, France

Location

Unknown Facility

Bordeaux, 33000, France

Location

Unknown Facility

Dijon, 21033, France

Location

Unknown Facility

Marseille, 13008, France

Location

Unknown Facility

Paris, 75015, France

Location

Unknown Facility

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Unknown Facility

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Unknown Facility

München, Bavaria, 81675, Germany

Location

Unknown Facility

Regensburg, Bavaria, 93053, Germany

Location

Unknown Facility

Hamburg, Hamburg, 20251, Germany

Location

Unknown Facility

Darmstadt, Hesse, 64297, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60596, Germany

Location

Unknown Facility

Marburg, Hesse, 35037, Germany

Location

Unknown Facility

Göttingen, Lower Saxony, 37075, Germany

Location

Unknown Facility

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Unknown Facility

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, 45122, Germany

Location

Unknown Facility

Münster, North Rhine-Westphalia, 48145, Germany

Location

Unknown Facility

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

Location

Unknown Facility

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Unknown Facility

Homburg, Saarland, 66421, Germany

Location

Unknown Facility

Chemnitz, Saxony, 09116, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Dresden, Saxony, 06067, Germany

Location

Unknown Facility

Leipzig, Saxony, 04103, Germany

Location

Unknown Facility

Kiel, Schleswig-Holstein, 24105, Germany

Location

Unknown Facility

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Budapest, 1089, Hungary

Location

Unknown Facility

Budapest, 1106, Hungary

Location

Unknown Facility

Budapest, 1133, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Veszprém, 8200, Hungary

Location

Unknown Facility

Zalaegerszeg, H-8900, Hungary

Location

Unknown Facility

Ancona, 60126, Italy

Location

Unknown Facility

Bari, 70124, Italy

Location

Unknown Facility

Catania, 95123, Italy

Location

Unknown Facility

Florence, 50134, Italy

Location

Unknown Facility

Milan, 20122, Italy

Location

Unknown Facility

Milan, 20132, Italy

Location

Unknown Facility

Milan, 20157, Italy

Location

Unknown Facility

Padua, 35128, Italy

Location

Unknown Facility

Roma, 00133, Italy

Location

Unknown Facility

Roma, 00198, Italy

Location

Unknown Facility

Torino, 10122, Italy

Location

Unknown Facility

Nagoya, Aichi-ken, 466-8560, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 467-8602, Japan

Location

Unknown Facility

Urayasu, Chiba, 279-0021, Japan

Location

Unknown Facility

Kyoto, Kyoto, 606-8507, Japan

Location

Unknown Facility

Suita, Osaka, 565-0871, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, 101-8309, Japan

Location

Unknown Facility

Riga, 1002, Latvia

Location

Unknown Facility

Riga, 1050, Latvia

Location

Unknown Facility

Singapore, 119074, Singapore

Location

Unknown Facility

Singapore, 168751, Singapore

Location

Unknown Facility

Seongnam-si, Gyeonggido, 463-707, South Korea

Location

Unknown Facility

Incheon, 405-760, South Korea

Location

Unknown Facility

Seoul, 110 744, South Korea

Location

Unknown Facility

Seoul, 137-701, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Publications (2)

• 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.

  PMID: 23298885 RESULT

• 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.

  PMID: 24084497 RESULT

Related Links

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

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 13, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: November 3, 2014
• Results First Posted: November 22, 2012

Record last verified: 2014-10

Locations

HU (6); KR (6); DE (25); IT (11); JP (6); LA (2); AU (3); FR (6); SG (2)