Conditions: Age-related Macular Degeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 271
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection. arm 2: Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection. arm 3: Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection. arm 4: Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection. arm 5: 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. arm 6: 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. arm 7: Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. arm 8: 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. arm 9: 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. arm 10: Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.

Interventions: intervention 1: AGN-150998 intervention 2: ranibizumab intervention 3: Sham Injection
Intervention descriptions: intervention 1: AGN-150998 Intravitreal injection. intervention 2: Ranibizumab 0.5 mg given by intravitreal injection. intervention 3: Stage 3: Sham injection at Weeks 12 and 16.

Protocol document: