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Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

NCT ID: NCT01397409

Last Updated: 2019-04-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-01

Study Completion Date

2014-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stage 1: AGN-150998 4.2 mg

Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

Stage 1: AGN-150998 3.0 mg

Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

Stage 1: AGN-150998 2.0 mg

Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

Stage 1: AGN-150998 1.0 mg

Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

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.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

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.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

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.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

Ranibizumab 0.5 mg given by intravitreal injection.

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.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

Sham Injection

Intervention Type OTHER

Stage 3: Sham injection at Weeks 12 and 16.

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.

Group Type EXPERIMENTAL

AGN-150998

Intervention Type DRUG

AGN-150998 Intravitreal injection.

Sham Injection

Intervention Type OTHER

Stage 3: Sham injection at Weeks 12 and 16.

Stage 3: ranibizumab 0.5 mg

Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

Ranibizumab 0.5 mg given by intravitreal injection.

Interventions

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AGN-150998

AGN-150998 Intravitreal injection.

Intervention Type DRUG

ranibizumab

Ranibizumab 0.5 mg given by intravitreal injection.

Intervention Type DRUG

Sham Injection

Stage 3: Sham injection at Weeks 12 and 16.

Intervention Type OTHER

Other Intervention Names

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Lucentis®

Eligibility Criteria

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Inclusion Criteria

* Exudative age-related macular degeneration
* Best-corrected visual acuity between 20/32 and 20/320 in the study eye

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Phoenix, Arizona, United States

Site Status

Sydney, New South Wales, Australia

Site Status

Vienna, , Austria

Site Status

Créteil, , France

Site Status

Bonn, , Germany

Site Status

Tel Aviv, , Israel

Site Status

Florence, , Italy

Site Status

Binningen, , Switzerland

Site Status

Countries

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United States Australia Austria France Germany Israel Italy Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 30412448 (View on PubMed)

Other Identifiers

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2011-002526-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REACH Study

Identifier Type: OTHER

Identifier Source: secondary_id

150998-001

Identifier Type: -

Identifier Source: org_study_id

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