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Safety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD

Sponsor
IVERIC bio, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05571267
Collaborator
(none)
1
Enrollment
3
Arms
18.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration
Actual Study Start Date :
Oct 20, 2016
Actual Primary Completion Date :
Apr 24, 2018
Actual Study Completion Date :
Apr 24, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Zimura and Avastin

Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura.

Drug: Zimura
Zimura 2 mg, administered by intravitreal injection
Other Names:
  • Avacincaptad Pegol
  • ARC1905

    • Drug: Avastin
    Avastin 1.25 mg, administered by intravitreal injection
    Other Names:
  • Bevacizumab

    		•
    Experimental: Zimura and Lucentis

    Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura.

    Drug: Zimura
    Zimura 2 mg, administered by intravitreal injection
    Other Names:
  • Avacincaptad Pegol
  • ARC1905

    • Drug: Lucentis
    Lucentis 0.5 mg, administered by intravitreal injection
    Other Names:
  • Ranibizumab

    		•
    Experimental: Zimura and Eylea

    Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura.

    Drug: Zimura
    Zimura 2 mg, administered by intravitreal injection
    Other Names:
  • Avacincaptad Pegol
  • ARC1905

    • Drug: Eylea
    Eylea 2 mg, administered by intravitreal injection
    Other Names:
  • Aflibercept

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants with >0 letter loss [Month 12]

      Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.

    2. Percentage of participants with >0 letter loss [Month 18]

      Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.

    3. Percentage of participants with >5 letter loss [Month 12]

      Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.

    4. Percentage of participants with >5 letter loss [Month 18]

      Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.

    5. Percentage of participants with >10 letter loss [Month 12 and Month 18]

      Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.

    6. Percentage of participants with >10 letter loss [Month 12]

      Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.

    7. Percentage of participants with >10 letter loss [Month 18]

      Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.

    • Presence of subfoveal active choroidal neovascularization (CNV)

    Exclusion Criteria:

    • Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.

    • Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.

    • Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.

    • Prior thermal laser in the macular region, regardless of indication.

    • Ocular or periocular infection in the past twelve weeks.

    • History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.

    • Previous therapeutic radiation in the region of the study eye.

    • Evidence of diabetic retinopathy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • IVERIC bio, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IVERIC bio, Inc.
    ClinicalTrials.gov Identifier:
    NCT05571267
    Other Study ID Numbers:
    • OPH2004
    First Posted:
    Oct 7, 2022
    Last Update Posted:
    Oct 7, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by IVERIC bio, Inc.
    Neovascular age-related macular degeneration (NVAMD)
    Additional relevant MeSH terms:
    Macular Degeneration
    Bevacizumab
    Ranibizumab
    Aflibercept

    Study Results

    No Results Posted as of Oct 7, 2022