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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01940887




Registration number
NCT01940887
Ethics application status
Date submitted
9/09/2013
Date registered
12/09/2013
Date last updated
30/09/2020

Titles & IDs
Public title
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® 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 Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Secondary ID [1] 0 0
OPH1004
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
Treatment: Drugs - bevacizumab or aflibercept
Treatment: Drugs - E10030 sham injection

Experimental: E10030 + bevacizumab or aflibercept - E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

Active Comparator: Sham + bevacizumab or aflibercept - E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection


Treatment: Drugs: E10030


Treatment: Drugs: bevacizumab or aflibercept
Patients are randomized to receive either bevacizumab or aflibercept

Treatment: Drugs: E10030 sham 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 (Measured at Baseline and at the Month 12 Visit) - The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
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
Gender
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
Terminated
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
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- Albury
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- Parramatta
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- Sydney
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- Westmead
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- East Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
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 outside Australia
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Valencia

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 either Avastin® or Eylea®
compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal
neovascularization secondary to age-related macular degeneration (AMD).
Trial website
https://clinicaltrials.gov/show/NCT01940887
Trial related presentations / publications
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
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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/show/NCT01940887