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

NCT01397409 | Completed Phase 2 Results

• 3 other identifiers: 150998-0012011-002526-43REACH Study
• Study Type: interventional
• Target: 271
• Locations: 7 countries
• Sites: 7

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.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (4)

• 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.

  24 Weeks

• 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.

  Baseline, Week 4

• 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.

  Baseline, Week 16

• 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.

  Baseline, Week 16

Secondary Outcomes (5)

• Stage 2: Time Between Second Treatment and Recurrence of Active Disease

  32 Weeks

• Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

  Baseline, Week 4

• Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

  Baseline, Week 4

• Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

  Baseline, Week 4

• Stage 3: Change From Baseline in BCVA in the Study Eye

  Baseline, Week 4

Study Arms (10)

Stage 1: AGN-150998 4.2 mg

EXPERIMENTAL

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

Drug: AGN-150998

Stage 1: AGN-150998 3.0 mg

EXPERIMENTAL

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

Drug: AGN-150998

Stage 1: AGN-150998 2.0 mg

EXPERIMENTAL

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

Drug: AGN-150998

Stage 1: AGN-150998 1.0 mg

EXPERIMENTAL

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

Drug: AGN-150998

Stage 2: AGN-150998 4.2 mg

EXPERIMENTAL

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.

Drug: AGN-150998

Stage 2: AGN-150998 3.0 mg

EXPERIMENTAL

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.

Drug: AGN-150998

Stage 2: ranibizumab 0.5 mg

ACTIVE COMPARATOR

Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.

Drug: ranibizumab

Stage 3: AGN-150998 2.0 mg

EXPERIMENTAL

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.

Drug: AGN-150998; Other: Sham Injection

Stage 3: AGN-150998 1.0 mg

EXPERIMENTAL

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.

Drug: AGN-150998; Other: Sham Injection

Stage 3: ranibizumab 0.5 mg

ACTIVE COMPARATOR

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

Drug: ranibizumab

Interventions

AGN-150998 DRUG

AGN-150998 Intravitreal injection.

Stage 1: AGN-150998 1.0 mg; Stage 1: AGN-150998 2.0 mg; Stage 1: AGN-150998 3.0 mg; Stage 1: AGN-150998 4.2 mg; Stage 2: AGN-150998 3.0 mg; Stage 2: AGN-150998 4.2 mg; Stage 3: AGN-150998 1.0 mg; Stage 3: AGN-150998 2.0 mg

ranibizumab DRUG

Ranibizumab 0.5 mg given by intravitreal injection.

Also known as: Lucentis®

Stage 2: ranibizumab 0.5 mg; Stage 3: ranibizumab 0.5 mg

Sham Injection OTHER

Stage 3: Sham injection at Weeks 12 and 16.

Stage 3: AGN-150998 1.0 mg; Stage 3: AGN-150998 2.0 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (8)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Sydney, New South Wales, Australia

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Créteil, France

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Florence, Italy

Location

Unknown Facility

Binningen, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30412448 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: September 1, 2011
• Primary Completion: March 31, 2014
• Study Completion: April 30, 2014
• Last Updated: April 16, 2019
• Results First Posted: June 18, 2015

Record last verified: 2019-04

Locations

AU (1); FR (1); IL (1); IT (1); US (1); DE (1); CH (1)