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Trial record 2 of 2 for:    NCT03525613

An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD (GALE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770545
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2021
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Brief Summary:
This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).

Condition or disease Intervention/treatment Phase
Geographic Atrophy Secondary to Age-related Macular Degeneration Drug: PEGCETACOPLAN (APL-2) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Actual Study Start Date : March 4, 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered monthly intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or monthly sham will receive IVT pegcetacoplan (15 mg/100 μL) monthly for up to approximately 36 months.
Drug: PEGCETACOPLAN (APL-2)
Complement (C3) Inhibitor

Experimental: Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered every other month (EOM) intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or EOM sham will receive IVT pegcetacoplan (15 mg/100 μL) EOM for up to approximately 36 months.
Drug: PEGCETACOPLAN (APL-2)
Complement (C3) Inhibitor




Primary Outcome Measures :
  1. Incidence and severity of ocular and systemic adverse events [ Time Frame: Up to 36 Months ]

Secondary Outcome Measures :
  1. Change from baseline in the total area of GA lesion(s) in the study eye (in mm2) [ Time Frame: Up to 36 Months ]
    The total area of GA lesion(s) in the study eye (in mm2) as assessed by FAF at Month 12, Month 24, and Month 36

  2. Change from baseline in NL-BCVA score (study eye) [ Time Frame: Up to 36 Months ]
    NL-BCVA score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Month 12, Month 24, and Month 36

  3. Change from baseline in LL-BCVA score (study eye) [ Time Frame: Up to 36 Months ]
    LL-BCVA score as assessed by ETDRS chart at Month 12, Month 24, and Month 36



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

Ocular-specific inclusion criteria apply to the study eye only.

  • Subjects must have participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600).
  • For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study.

    • Subjects who did not fully stop study drug treatment, but missed the visit at Month 24, can also participate in the study. However, to participate, subjects must be seen within 60 days from the last day of the period allowed for the 24 months visit in the previous study.
  • The eyes of subjects must have transparency to permit visualization of parts inside the eye such as the retina and subjects must be able to look steadily at a provided target allowing the doctor to get good quality pictures from the eye.
  • Female subjects must be:

    • Women that cannot have children, or
    • Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication.
  • Males with female partners who can get pregnant must also agree to use ways to avoid pregnancy and agree not to donate sperm while in the study or until 90 days after administering the last dose of the study medication.
  • Agree to participate in the study by signing the consent document providing information about the study; and take part in all tests and assessments as required.

Exclusion Criteria:

Subjects cannot take part in the study if the eye that will be treated during the study currently meets any of the following conditions:

  • Participants in APL2 303/304 studies who fully stopped study drug treatment before the visit in month 24 but remain in the study to observe the study medication's safety. Those subjects who temporarily paused study drug treatment are still eligible to participate.
  • If, according to your doctor you currently have any disease affecting your eyes that could interfere with your vision, including diseases that affect your retina or macula (the center of the back of your eyes). And, if according to your doctor, the disease in your eyes is benign and does not interfere with the study (e.g. diseases that affects the periphery of the retina), you are also eligible to take part in the study.
  • If, according to your doctor you currently have any inflammation/infection in or around your eyes that could prohibit you from receiving an injection inside your eyes.
  • If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three yearsover the next 36 months.
  • If you have known allergies to fluorescein sodium, a solution that is injected into your body for eye testing; or to pegcetacoplan (the study drug) or any inactive substances in pegcetacoplan solution.
  • If you currently are pregnant, breastfeed or have a positive pregnancy test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770545


Locations
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United States, California
California Retina Consultants
Bakersfield, California, United States, 93309
The Retina Partners
Encino, California, United States, 91436
Retina Institute of California Medical Group
Palm Desert, California, United States, 92260
United States, Colorado
Southwest Retina Research Center, LLC
Durango, Colorado, United States, 81301
United States, Florida
Retina Specialty Institute
Pensacola, Florida, United States, 32503
United States, Georgia
Southeast Retina Center, PC
Augusta, Georgia, United States, 30909
United States, Maryland
Mid Atlantic Retina Specialist
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Michigan
Associated Retinal Consultants, PC
Grand Rapids, Michigan, United States, 49546
United States, New York
Ophthalmic Consultants of Long Island
Oceanside, New York, United States, 11572
United States, North Carolina
Western Carolina Retinal Associates
Asheville, North Carolina, United States, 28803
Charlotte Eye Ear Nose and Throat Associates, PS
Charlotte, North Carolina, United States, 28210
United States, Texas
Retina Consultants of Houston, PA
Houston, Texas, United States, 77030
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
United States, Wisconsin
Retina-Vitreous Associates Medical Group
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04770545    
Other Study ID Numbers: APL2-GA-305
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Macular Degeneration
Geographic Atrophy
Atrophy
Neoplastic Processes
Neoplasms
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical