Phase 2 N=24 Randomized Quadruple-blind Treatment

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

Age-related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT01397409 ↗

Enrolled (actual)

Serious AEs

8.5%

Results posted

Jun 2015

Primary outcome: Primary: Highest Tolerated Dose (HTD) of AGN-150998 — 4.2 mg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AGN-150998 (Drug); ranibizumab (Drug); Sham Injection (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Highest Tolerated Dose (HTD) of AGN-150998	4.2	—
PRIMARY Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	527.6; 540.3; 500.3; 564.3; -185.4; -239.5	—
PRIMARY Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease	59.0; 57.0; 57.0	—
PRIMARY Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	58.5; 58.4; 60.4; 8.2; 6.3; 5.3	—
SECONDARY Stage 2: Time Between Second Treatment and Recurrence of Active Disease	85.0; 112.0; 111.0	—
SECONDARY Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	524.6; 507.3; 497.1; -179.5; -155.3; -157.3	—
SECONDARY Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	54.5; 52.7; 55.4; 4.7; 8.4; 5.9	—
SECONDARY Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	466.0; 526.1; 463.3; -119.8; -168.3; -98.4	—
SECONDARY Stage 3: Change From Baseline in BCVA in the Study Eye	58.5; 58.4; 60.4; 5.0; 4.6; 3.9	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01397409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.