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

Allergan

Status and phase: Completed; Phase 2

Conditions: Age-related Macular Degeneration

Treatments: Other: Sham Injection; Drug: ranibizumab; Drug: AGN-150998

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397409

REACH Study (Other Identifier)

2011-002526-43 (EudraCT Number)

150998-001

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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271 participants in 10 patient groups

Stage 1: AGN-150998 4.2 mg

Experimental group

Description:

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

Treatment:

Drug: AGN-150998

Stage 1: AGN-150998 3.0 mg

Experimental group

Description:

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

Treatment:

Drug: AGN-150998

Stage 1: AGN-150998 2.0 mg

Experimental group

Description:

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

Treatment:

Drug: AGN-150998

Stage 1: AGN-150998 1.0 mg

Experimental group

Description:

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

Treatment:

Drug: AGN-150998

Stage 2: AGN-150998 4.2 mg

Experimental group

Description:

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.

Treatment:

Drug: AGN-150998

Stage 2: AGN-150998 3.0 mg

Experimental group

Description:

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.

Treatment:

Drug: AGN-150998

Stage 2: ranibizumab 0.5 mg

Active Comparator group

Description:

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

Treatment:

Drug: ranibizumab

Stage 3: AGN-150998 2.0 mg

Experimental group

Description:

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.

Treatment:

Drug: AGN-150998

Other: Sham Injection

Stage 3: AGN-150998 1.0 mg

Experimental group

Description:

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.

Treatment:

Drug: AGN-150998

Other: Sham Injection

Stage 3: ranibizumab 0.5 mg

Active Comparator group

Description:

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

Treatment:

Drug: ranibizumab