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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
Scientific title
Secondary ID [1] 0 0
2011-002526-43
Secondary ID [2] 0 0
150998-001
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 - 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.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Highest Tolerated Dose (HTD) of AGN-150998 - Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Timepoint [1] 0 0
24 Weeks
Primary outcome [2] 0 0
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye - 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.
Timepoint [2] 0 0
Baseline, Week 4
Primary outcome [3] 0 0
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease - 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.
Timepoint [3] 0 0
Baseline, Week 16
Primary outcome [4] 0 0
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye - 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.
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Stage 2: Time Between Second Treatment and Recurrence of Active Disease - 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.
Timepoint [1] 0 0
32 Weeks
Secondary outcome [2] 0 0
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye - 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.
Timepoint [2] 0 0
Baseline, Week 4
Secondary outcome [3] 0 0
Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye - 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.
Timepoint [3] 0 0
Baseline, Week 4
Secondary outcome [4] 0 0
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye - 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.
Timepoint [4] 0 0
Baseline, Week 4
Secondary outcome [5] 0 0
Stage 3: Change From Baseline in BCVA in the Study Eye - 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.
Timepoint [5] 0 0
Baseline, Week 4

Eligibility
Key inclusion criteria
- Exudative age-related macular degeneration

- Best-corrected visual acuity between 20/32 and 20/320 in the study eye
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
France
State/province [3] 0 0
Créteil
Country [4] 0 0
Germany
State/province [4] 0 0
Bonn
Country [5] 0 0
Israel
State/province [5] 0 0
Tel Aviv
Country [6] 0 0
Italy
State/province [6] 0 0
Firenze
Country [7] 0 0
Switzerland
State/province [7] 0 0
Binningen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01397409
Trial related presentations / publications
Callanan D, Kunimoto D, Maturi RK, Patel SS, Staurenghi G, Wolf S, Cheetham JK, Hohman TC, Kim K, López 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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
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
Other publications