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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Timepoint [2] 0 0
Baseline, Week 4
Primary outcome [3] 0 0
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
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
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
Stage 2: Time Between Second Treatment and Recurrence of Active Disease
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
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
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
Timepoint [4] 0 0
Baseline, Week 4
Secondary outcome [5] 0 0
Stage 3: Change From Baseline in BCVA in the Study Eye
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
Sex
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
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2014
Sample size
Target
Accrual to date
Final
271
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/study/NCT01397409
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01397409