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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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