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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01397409
Registration number
NCT01397409
Ethics application status
Date submitted
18/07/2011
Date registered
19/07/2011
Date last updated
16/04/2019
Titles & IDs
Public title
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
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Scientific title
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Secondary ID [1]
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2011-002526-43
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Secondary ID [2]
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150998-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Age-related Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AGN-150998
Treatment: Drugs - ranibizumab
Other interventions - Sham Injection
Experimental: Stage 1: AGN-150998 4.2 mg - Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection.
Experimental: Stage 1: AGN-150998 3.0 mg - Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
Experimental: Stage 1: AGN-150998 2.0 mg - Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
Experimental: Stage 1: AGN-150998 1.0 mg - Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
Experimental: Stage 2: AGN-150998 4.2 mg - Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Experimental: Stage 2: AGN-150998 3.0 mg - Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Active Comparator: Stage 2: ranibizumab 0.5 mg - Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Experimental: Stage 3: AGN-150998 2.0 mg - Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
Experimental: Stage 3: AGN-150998 1.0 mg - Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
Active Comparator: Stage 3: ranibizumab 0.5 mg - Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
Treatment: Drugs: AGN-150998
AGN-150998 Intravitreal injection.
Treatment: Drugs: ranibizumab
Ranibizumab 0.5 mg given by intravitreal injection.
Other interventions: Sham Injection
Stage 3: Sham injection at Weeks 12 and 16.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Highest Tolerated Dose (HTD) of AGN-150998
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Assessment method [1]
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Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
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Timepoint [1]
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24 Weeks
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Primary outcome [2]
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Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
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Assessment method [2]
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CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
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Timepoint [2]
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Baseline, Week 4
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Primary outcome [3]
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Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
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Assessment method [3]
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Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
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Timepoint [3]
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Baseline, Week 16
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Primary outcome [4]
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Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
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Assessment method [4]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
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Timepoint [4]
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Baseline, Week 16
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Secondary outcome [1]
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Stage 2: Time Between Second Treatment and Recurrence of Active Disease
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Assessment method [1]
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Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.
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Timepoint [1]
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32 Weeks
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Secondary outcome [2]
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Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
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Assessment method [2]
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CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
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Timepoint [2]
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Baseline, Week 4
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Secondary outcome [3]
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Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
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Assessment method [3]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
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Timepoint [3]
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Baseline, Week 4
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Secondary outcome [4]
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Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
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Assessment method [4]
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CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
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Timepoint [4]
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Baseline, Week 4
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Secondary outcome [5]
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Stage 3: Change From Baseline in BCVA in the Study Eye
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Assessment method [5]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
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Timepoint [5]
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Baseline, Week 4
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Eligibility
Key inclusion criteria
- Exudative age-related macular degeneration
- Best-corrected visual acuity between 20/32 and 20/320 in the study eye
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Near-sightedness of 8 diopters or more
- Uncontrolled glaucoma in the study eye
- Cataract surgery or Lasik within the last 3 months
- Any active ocular infection or inflammation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/04/2014
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Sample size
Target
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Accrual to date
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Final
271
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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Austria
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State/province [2]
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Vienna
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Country [3]
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France
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State/province [3]
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Créteil
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Germany
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State/province [4]
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Bonn
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Israel
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State/province [5]
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Tel Aviv
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Country [6]
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Italy
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State/province [6]
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Firenze
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Country [7]
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Switzerland
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State/province [7]
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Binningen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of
the safety of AGN-150998 administered as a single intravitreal injection to patients with
advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are
randomized, double-masked, comparisons of the safety and treatment effects on retinal edema
and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive
patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a
fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest
tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on
retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of
AGN-150998.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01397409
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Trial related presentations / publications
Callanan D, Kunimoto D, Maturi RK, Patel SS, Staurenghi G, Wolf S, Cheetham JK, Hohman TC, Kim K, Lopez FJ, Schneider S. Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. J Ocul Pharmacol Ther. 2018 Dec;34(10):700-709. doi: 10.1089/jop.2018.0062. Epub 2018 Nov 9.
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01397409
Download to PDF