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Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) (VIEW1)

This study has been completed.

Sponsor:

Collaborator:

Bayer

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00509795

First received: July 31, 2007

Last updated: December 20, 2012

Last verified: December 2012

History of Changes

Results First Received: December 16, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Macular Degeneration
Interventions:	Biological: ranibizumab Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

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
The study was conducted at 164 sites in the United States and Canada. Recruitment period: 02 Aug 2007 to 15 Sep 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2063 patients were screened, 1217 randomized, and 1215 included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 1210 patients with at least 1 post-baseline assessment. The Per Protocol Set (PPS) included 1089 patients who received ≥ 9 doses of study drug and attended ≥ 9 scheduled visits during the first year.

Reporting Groups

	Description
Ranibizumab 0.5mg Q4	Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4	Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4	Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8	Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.

Participant Flow: Overall Study

	Ranibizumab 0.5mg Q4	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8
STARTED	306	304	304	303
Patients Received Treatment (SAF)	304	304	304	303
Full Analysis Set (FAS) Population	304	304	301	301
Per Protocol Set (PPS) Population	269	285	270	265
COMPLETED	284	293	277	276
NOT COMPLETED	22	11	27	27
Adverse Event	4	3	5	4
Death	3	1	2	7
Lack of Efficacy	0	0	2	2
Lost to Follow-up	1	2	4	4
OTHER	1	0	4	1
Protocol Violation	3	0	3	1
Withdrawal by Subject	10	5	7	8

Baseline Characteristics

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Reporting Groups

	Description
Ranibizumab 0.5mg Q4	Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4	Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4	Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8	Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
Total	Total of all reporting groups

Baseline Measures

	Ranibizumab 0.5mg Q4	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4	IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4	IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8	Total
Number of Participants [units: participants]	304	304	304	303	1215
Age ^[1] [units: years] Mean ± Standard Deviation	78.2 ± 7.59	77.7 ± 7.93	78.3 ± 8.10	77.9 ± 8.39	78.0 ± 8.00
Gender [units: patients]
Female	172	194	169	179	714
Male	132	110	135	124	501
Ethnicity (NIH/OMB) ^[1] [units: patients]
Hispanic or Latino	7	11	11	12	41
Not Hispanic or Latino	297	293	293	291	1174
Unknown or Not Reported	0	0	0	0	0
Race (NIH/OMB) ^[1] [units: patients]
American Indian or Alaska Native	2	0	2	1	5
Asian	0	3	5	4	12
Native Hawaiian or Other Pacific Islander	1	0	0	1	2
Black or African American	1	1	0	1	3
White	296	295	294	289	1174
More than one race	0	0	0	1	1
Unknown or Not Reported	4	5	3	6	18
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score ^[2] [units: scores on a scale] Mean ± Standard Deviation	71.7 ± 17.29	70.4 ± 16.60	71.1 ± 17.72	69.5 ± 16.82	70.7 ± 17.11
Baseline Area of Choroidal Neovascularization (CNV) ^[1] [units: mm^2] Mean ± Standard Deviation	6.52 ± 5.245	6.59 ± 5.052	6.49 ± 4.437	6.56 ± 5.129	6.54 ± 4.968
Baseline Lesion Type ^[1] [units: patients]
Occult	115	110	123	118	466
Minimally Classic	101	105	97	112	415
Predominantly Classic	82	87	82	71	322
Missing	6	2	2	2	12
Baseline Total Lesion Size ^[1] [units: mm^2] Mean ± Standard Deviation	6.99 ± 5.491	6.98 ± 5.388	6.96 ± 4.711	6.88 ± 5.214	6.95 ± 5.202
Baseline Best Corrected Visual Acuity (BCVA) ^[3] [units: letters read] Mean ± Standard Deviation	54.0 ± 13.43	55.2 ± 13.15	55.5 ± 13.12	55.7 ± 12.84	55.1 ± 13.14

[1]	SAF population used for analysis.
[2]	SAF population used for analysis. 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.
[3]	SAF population used for analysis. BCVA assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart. For BCVA tested via the 4 meter ETDRS protocol, 83 letters or more would represent 20/20 vision or better which would be considered an excellent outcome. Although, the ETDRS charts include 100 letters as the maximum possible score. The worst outcome is 0 letters read.

Outcome Measures

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1. Primary:

Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and at week 52 ]

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2. Secondary:

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF [ Time Frame: Baseline and at week 52 ]

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3. Secondary:

Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF. [ Time Frame: Baseline and at week 52 ]

Show Outcome Measure 3

4. Secondary:

Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF [ Time Frame: Baseline and at Week 52 ]

Show Outcome Measure 4

5. Secondary:

Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF) [ Time Frame: Baseline and at week 52 ]

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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: After completion of the trial, 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 from the time submitted to the sponsor for review; provided that the sponsor can remove confidential or proprietary information from such communications. The sponsor cannot require other changes to the communication and cannot extend the embargo.

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
No text entered.

Results Point of Contact:

Name/Title: Clinical Trials Administrator
Organization: Regeneron Pharmaceuticals
e-mail: clinicaltrials@regeneron.com

No publications provided

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00509795 History of Changes
Other Study ID Numbers:	VGFT-OD-0605
Study First Received:	July 31, 2007
Results First Received:	December 16, 2011
Last Updated:	December 20, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

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