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

This study has been completed.

Sponsor:

Collaborator:

Regeneron Pharmaceuticals

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01012973

First received: October 30, 2009

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Results First Received: October 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Retinal Vein Occlusion
Interventions:	Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) Other: Sham treatment

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Aflibercept Injection First, Then Aflibercept Injection	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 Treatment First, Then Aflibercept Injection	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.

Participant Flow: Overall Study

	Aflibercept Injection First, Then Aflibercept Injection	Sham Treatment First, Then Aflibercept Injection
STARTED	106	71
Participants Received Treatment	104 ^[1]	68 ^[1]
Fulfilled Requirements of FAS Population	103 ^[2]	68 ^[2]
Completed Week 24, From FAS	97	57
Completed Week 52, From FAS	91	52
COMPLETED	90	52
NOT COMPLETED	16	19
Adverse Event	5	5
Lack of Efficacy	0	5
Lost to Follow-up	1	0
(Overseas travel - indefinite period)	1	0
Increase in vis. acuity, never injected	0	1
Protocol Violation	5	2
Withdrawal by Subject	4	6

[1]	Safety Population: Participants received treatment
[2]	Full Analysis Set (FAS) Population: Participants received treatment with post baseline measurements

Baseline Characteristics

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Reporting Groups

	Description
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 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.
Total	Total of all reporting groups

Baseline Measures

	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	Sham Treatment	Total
Number of Participants [units: participants]	104	68	172
Age [units: Years] Mean ± Standard Deviation	60.0 ± 12.3	63.8 ± 13.3	61.5 ± 12.8
Gender [units: Participants]
Female	45	31	76
Male	59	37	96
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	4	1	5
Not Hispanic or Latino	100	66	166
Unknown or Not Reported	0	1	1
Baseline Best Corrected Visual Acuity (BCVA) letter scores ^[1] [units: Letters correctly read] Mean ± Standard Deviation	53.5 ± 15.7	50.9 ± 15.4	52.5 ± 15.6
Number of participants with baseline retinal perfusion ^[2] [units: Participants]
Perfused	90	54	144
Nonperfused	7	7	14
Indeterminate	7	7	14
Baseline Retinal Thickness by Optical Coherence Tomography (OCT) [units: microns] Mean ± Standard Deviation	682.78 ± 233.36	638.66 ± 224.69	665.34 ± 230.33
Baseline intraocular pressure [units: mm Hg] Mean ± Standard Deviation	15.2 ± 2.8	14.4 ± 2.7	14.9 ± 2.8
Number of participants with time since Central retinal vein occlusion (CRVO) diagnosis [units: Participants]
>= 2 months	46	33	79
< 2 months	56	35	91
Missing	2	0	2
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score ^[3] [units: scores on a scale] Mean ± Standard Deviation	79.66 ± 13.06	78.94 ± 14.00	79.38 ± 13.40
European questionnaire 5 dimensions (EQ-5D) total score ^[4] [units: score on a scale] Mean ± Standard Deviation	0.87 ± 0.15	0.86 ± 0.16	0.87 ± 0.15
Race [units: Participants]
Asian	26	15	41
White	75	49	124
Unknown or Not Reported	3	4	7

[1]	Infiormation retrieved from all baseline participants. Only participants with a ETDRS (Early Treatment Diabetic Retinopathy Study) Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters were included; a higher score represents better functioning.
[2]	Retinal perfusion defined as less than 10 disc areas of capillary nonperfusion using fluorescein angiography (FA)
[3]	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.
[4]	The EQ-5D total score ranges from -0.594 to 1.000 with -0.594 being the worst.

Outcome Measures

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1. Primary:

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 [ Time Frame: Baseline and Week 24 ]

Show Outcome Measure 1

2. Secondary:

Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and Week 24 ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [ Time Frame: Baseline and Week 24 ]

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4. Secondary:

Percentage of Participants Who Developed Neovascularization During the First 24 Weeks [ Time Frame: From baseline until Week 24 ]

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5. Secondary:

Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF [ Time Frame: Baseline and Week 24 ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF [ Time Frame: Baseline and Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Publishing of result communication only after Bayer´s written approval. Manuscript to Bayer sixty days before public release. If no written Bayer comment within 60 days consider approval given. If multi-site study, principal investigator (PI) not do independently publish results before publication of the multi-site paper, but PI not restricted from 24 months from study to completion onwards.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT01012973 History of Changes
Other Study ID Numbers:	14130, 2009-010973-19
Study First Received:	October 30, 2009
Results First Received:	October 23, 2012
Last Updated:	January 18, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hungary: National Institute of Pharmacy Italy: Ministry of Health Latvia: State Agency of Medicines Japan: Pharmaceuticals and Medical Devices Agency Singapore: Health Sciences Authority South Korea: Korea Food and Drug Administration (KFDA)

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