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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01012973




Registration number
NCT01012973
Ethics application status
Date submitted
30/10/2009
Date registered
13/11/2009
Date last updated
3/11/2014

Titles & IDs
Public title
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Scientific 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)
Secondary ID [1] 0 0
2009-010973-19
Secondary ID [2] 0 0
14130
Universal Trial Number (UTN)
Trial acronym
GALILEO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Other interventions - Sham treatment

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

Sham Comparator: Sham treatment - 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 interventions: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
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.

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF) - Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Percentage of Participants Who Developed Neovascularization During the First 24 Weeks - Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24
Timepoint [3] 0 0
From baseline until Week 24
Secondary outcome [4] 0 0
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF - The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF - EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).
Timepoint [5] 0 0
Baseline and Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Chatswood
Recruitment hospital [2] 0 0
- Parramatta
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Westmead
Recruitment hospital [5] 0 0
- East Melbourne
Recruitment hospital [6] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
France
State/province [4] 0 0
Cedex 12
Country [5] 0 0
France
State/province [5] 0 0
Cedex 1
Country [6] 0 0
France
State/province [6] 0 0
Bordeaux
Country [7] 0 0
France
State/province [7] 0 0
Dijon
Country [8] 0 0
France
State/province [8] 0 0
Marseille
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Baden-Württemberg
Country [11] 0 0
Germany
State/province [11] 0 0
Bayern
Country [12] 0 0
Germany
State/province [12] 0 0
Hessen
Country [13] 0 0
Germany
State/province [13] 0 0
Niedersachsen
Country [14] 0 0
Germany
State/province [14] 0 0
Nordrhein-Westfalen
Country [15] 0 0
Germany
State/province [15] 0 0
Rheinland-Pfalz
Country [16] 0 0
Germany
State/province [16] 0 0
Saarland
Country [17] 0 0
Germany
State/province [17] 0 0
Sachsen
Country [18] 0 0
Germany
State/province [18] 0 0
Schleswig-Holstein
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Hamburg
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Hungary
State/province [22] 0 0
Debrecen
Country [23] 0 0
Hungary
State/province [23] 0 0
Veszprem
Country [24] 0 0
Hungary
State/province [24] 0 0
Zalaegerszeg
Country [25] 0 0
Italy
State/province [25] 0 0
Ancona
Country [26] 0 0
Italy
State/province [26] 0 0
Bari
Country [27] 0 0
Italy
State/province [27] 0 0
Catania
Country [28] 0 0
Italy
State/province [28] 0 0
Firenze
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Padova
Country [31] 0 0
Italy
State/province [31] 0 0
Roma
Country [32] 0 0
Italy
State/province [32] 0 0
Torino
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi
Country [34] 0 0
Japan
State/province [34] 0 0
Chiba
Country [35] 0 0
Japan
State/province [35] 0 0
Osaka
Country [36] 0 0
Japan
State/province [36] 0 0
Tokyo
Country [37] 0 0
Japan
State/province [37] 0 0
Kyoto
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Gyeonggido
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Incheon
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Latvia
State/province [41] 0 0
Riga
Country [42] 0 0
Singapore
State/province [42] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT01012973
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications