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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01397409
Recruitment Status : Completed
First Posted : July 19, 2011
Results First Posted : June 18, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: AGN-150998 Drug: ranibizumab Other: Sham Injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : September 1, 2011
Actual Primary Completion Date : March 31, 2014
Actual Study Completion Date : April 30, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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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 Name: 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 Name: Lucentis®


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397409


Locations
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United States, Arizona
Phoenix, Arizona, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Austria
Vienna, Austria
France
Créteil, France
Germany
Bonn, Germany
Israel
Tel Aviv, Israel
Italy
Firenze, Italy
Switzerland
Binningen, Switzerland
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01397409    
Other Study ID Numbers: 150998-001
2011-002526-43 ( EudraCT Number )
REACH Study ( Other Identifier: Allergan, Inc. )
First Posted: July 19, 2011    Key Record Dates
Results First Posted: June 18, 2015
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents