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

April 9, 2019 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection.
Drug: AGN-150998
AGN-150998 Intravitreal injection.
Experimental: Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
Drug: AGN-150998
AGN-150998 Intravitreal injection.
Experimental: Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
Drug: AGN-150998
AGN-150998 Intravitreal injection.
Experimental: Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
Drug: AGN-150998
AGN-150998 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.
Drug: AGN-150998
AGN-150998 Intravitreal injection.
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.
Drug: AGN-150998
AGN-150998 Intravitreal injection.
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.
Drug: ranibizumab
Ranibizumab 0.5 mg given by intravitreal injection.
Other Names:
  • Lucentis®
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.
Drug: AGN-150998
AGN-150998 Intravitreal injection.
Other: Sham Injection
Stage 3: Sham injection 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.
Drug: AGN-150998
AGN-150998 Intravitreal injection.
Other: Sham Injection
Stage 3: Sham injection 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.
Drug: ranibizumab
Ranibizumab 0.5 mg given by intravitreal injection.
Other Names:
  • Lucentis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Highest Tolerated Dose (HTD) of AGN-150998
Time Frame: 24 Weeks
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
Time Frame: Baseline, Week 4
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
Time Frame: Baseline, Week 16
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
Time Frame: Baseline, Week 16
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage 2: Time Between Second Treatment and Recurrence of Active Disease
Time Frame: 32 Weeks
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.
32 Weeks
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time Frame: Baseline, Week 4
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: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline, Week 4
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 4
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time Frame: Baseline, Week 4
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 3: Change From Baseline in BCVA in the Study Eye
Time Frame: Baseline, Week 4
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 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

March 31, 2014

Study Completion (Actual)

April 30, 2014

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150998-001
  • 2011-002526-43 (EudraCT Number)
  • REACH Study (Allergan, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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