Open-Label Extension for Subjects Who Previously Completed Phase 3 Study ISEE2008.

• Sponsor: IVERIC bio, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05536297
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 14.3

Study Details

Study Description

Brief Summary

Patients who completed Study ISEE2008 (GATHER2) and consent to participate will be administered monthly avacincaptad pegol 2 mg.

Condition or Disease	Intervention/Treatment	Phase
Geographic Atrophy; Macular Degeneration	Drug: Avacincaptad pegol 2 mg intravitreal injection	Phase 3

Detailed Description

Approximately 400 patients who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham) and consent to participate will be administered monthly avacincaptad pegol 2 mg from Month 1 through Month 17 (maximum 17 total doses); or until avacincaptad pegol is commercially available. All patients will have a final follow up visit at Month 18.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Avacincaptad pegol 2 mg Avacincaptad pegol 2 mg administered monthly from Month 1 to Month 17	Drug: Avacincaptad pegol 2 mg intravitreal injection; Avacincaptad pegol is a complement C5 inhibitor; Other Names: Zimura ARC1905

Outcome Measures

Primary Outcome Measures

1. Adverse Events [Month 18]

   To assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment.

• Patient must provide new written informed consent for this OLE trial prior to participation.

• Patient must have the ability to return for all trial visits for the duration of the 18-month trial.

Exclusion Criteria:

• Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham),

• Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.

• Patient did not enroll into this OLE trial within the 90 day enrollment period.

• Patient who is pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Foundation of the Southwest	Dallas	Texas	United States	75231

Sponsors and Collaborators

• IVERIC bio, Inc.

Investigators

• Study Chair: Medical Director, IVERIC bio, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IVERIC bio, Inc.
• ClinicalTrials.gov Identifier: NCT05536297
• Other Study ID Numbers: ISEE2009
• First Posted: Sep 10, 2022
• Last Update Posted: Sep 10, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy

Study Results

No Results Posted as of Sep 10, 2022