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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01940900




Registration number
NCT01940900
Ethics application status
Date submitted
9/09/2013
Date registered
12/09/2013
Date last updated
30/10/2024

Titles & IDs
Public title
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Scientific title
A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Secondary ID [1] 0 0
OPH1003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - E10030 sham intravitreal injection

Experimental: E10030 + ranibizumab - E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

Active comparator: Sham + ranibizumab - E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection


Treatment: Drugs: E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Visual Acuity From Baseline to 12 Months
Timepoint [1] 0 0
12 Months

Eligibility
Key inclusion criteria
* Subjects of either gender aged = 50 years
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Presence of sub-retinal hyper-reflective material (SD-OCT)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
* Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
* Subjects with subfoveal scar or subfoveal atrophy are excluded
* Diabetes mellitus

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 administering 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
627
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- East Melbourne
Recruitment hospital [2] 0 0
- Malvern
Recruitment hospital [3] 0 0
- Nedlands
Recruitment hospital [4] 0 0
- Parramatta
Recruitment hospital [5] 0 0
- Sydney
Recruitment hospital [6] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
2150 - Parramatta
Recruitment postcode(s) [5] 0 0
2000 - Sydney
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Aalborg
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Luebeck
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Mainz
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Budapest
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Debrecen
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Pecs
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ophthotech Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Trial website
https://clinicaltrials.gov/study/NCT01940900
Trial related presentations / publications
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01940900