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

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01397409

Purpose

This study is conducted in 2 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as an intravitreal injection to patients with exudative Age-related Macular Degeneration (AMD). Stage 2 is a randomized, double-masked, comparison of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in patients with exudative AMD. 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	Intervention	Phase
Age-related Macular Degeneration	Drug: AGN-150998 Drug: ranibizumab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Stage 1: Highest Tolerated Dose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Stage 2: Central Retinal Thickness as Assessed by Spectral Domain Optical Coherence Tomography (OCT) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stage 2: Central Retinal Subfield Thickness (CRT) as Assessed by Spectral Domain Optical Coherence Tomography (OCT) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Stage 2: Best Corrected Visual Acuity (BCVA) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Stage 2: Serum Levels of AGN-150998 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Stage 1: Serum Levels of AGN-150998 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stage 1: AGN-150998 Dose 1 Stage 1: AGN-150998 Dose 1	Drug: AGN-150998 Stage 1: AGN-150998 Dose 1 given as a single intravitreal injection
Experimental: Stage 1: AGN-150998 Dose 2 Stage 1: AGN-150998 Dose 2	Drug: AGN-150998 Stage 1: AGN-150998 Dose 2 given as a single intravitreal injection
Experimental: Stage 1: AGN-150998 Dose 3 Stage 1: AGN-150998 Dose 3	Drug: AGN-150998 Stage 1: AGN-150998 Dose 3 given as a single intravitreal injection
Experimental: Stage 1: AGN-150998 Dose 4 Stage 1: AGN-150998 Dose 4	Drug: AGN-150998 Stage 1: AGN-150998 Dose 4 given as a single intravitreal injection
Experimental: Stage 2: AGN-150998 Highest Tolerated Dose from Stage 1 Stage 2: AGN-150998 Highest Tolerated Dose from Stage 1	Drug: AGN-150998 Stage 2: AGN-150998 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 One Dose Below HTD from Stage 1 Stage 2: AGN-150998 One Dose Below Highest Tolerated Dose (HDT) from Stage 1	Drug: AGN-150998 Stage 2: AGN-150998 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	Drug: ranibizumab Stage 2: ranibizumab 5.0 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. Other Name: Lucentis®

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age-related macular degeneration
Best-corrected visual acuity between 20/40 and 20/800

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397409

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, Arizona
	Recruiting
Phoenix, Arizona, United States
France
	Not yet recruiting
Créteil, France

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

More Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01397409 History of Changes
Other Study ID Numbers:	150998-001, 2011-002526-43, REACH Study
Study First Received:	July 18, 2011
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2012