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

Age-related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397409
• Other study ID #: 150998-001
• Secondary ID: 2011-002526-43RE
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2011
• Est. completion date: April 30, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: April 30, 2014
• Est. primary completion date: March 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• AGN-150998
AGN-150998 Intravitreal injection.
• ranibizumab
Ranibizumab 0.5 mg given by intravitreal injection.

Other:
• Sham Injection
Stage 3: Sham injection at Weeks 12 and 16.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Austria,  France,  Germany,  Israel,  Italy,  Switzerland, 

References & Publications (1)

Callanan D, Kunimoto D, Maturi RK, Patel SS, Staurenghi G, Wolf S, Cheetham JK, Hohman TC, Kim K, López FJ, Schneider S. Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. J Ocul Pharmacol Ther. 2018 Nov 9. doi: 10.1089/jop.2018.0062. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highest Tolerated Dose (HTD) of AGN-150998	Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.	24 Weeks
Primary	Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	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.	Baseline, Week 4
Primary	Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease	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.	Baseline, Week 16
Primary	Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	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.	Baseline, Week 16
Secondary	Stage 2: Time Between Second Treatment and Recurrence of Active Disease	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.	32 Weeks
Secondary	Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	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.	Baseline, Week 4
Secondary	Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	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.	Baseline, Week 4
Secondary	Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	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.	Baseline, Week 4
Secondary	Stage 3: Change From Baseline in BCVA in the Study Eye	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.	Baseline, Week 4