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Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy

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ClinicalTrials.gov Identifier: NCT03777332
Recruitment Status : Active, not recruiting
First Posted : December 17, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Brief Summary:
Safety Assessment of APL-2 in Patients with Geographic Atrophy

Condition or disease Intervention/treatment Phase
Geographic Atrophy Drug: APL-2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-Month Phase Ib Multi-Center, Open Label, Single Arm Study to Evaluate the Safety of Intravitreal APL-2 Therapy in Patients Diagnosed With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APL-2 15 mg/0.1 mL Monthly for 24 months Drug: APL-2
Complement (C3) Inhibitor




Primary Outcome Measures :
  1. Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 25 Months ]


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:

Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.

  1. Age greater than or equal to 60 years.
  2. Normal Luminance best corrected visual acuity of between 35 and 5 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately between 20/200 and 20/800 Snellen equivalent).
  3. Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
  4. The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:

    1. Total GA area must be ≥ 2.5 (1 disk areas [DA]).
    2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 4a.
  5. Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
  6. Female subjects must be:

    1. Women of non-child-bearing potential (WONCBP), or
    2. Women of child-bearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
  7. Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
  8. Willing and able to give informed consent and to comply with the study procedures and assessments.

Exclusion Criteria:

Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.

  1. GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
  2. Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
  3. Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
  4. Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane [ERM], full thickness macular hole) or uncontrolled glaucoma/ocular hypertension). Benign conditions in the opinion of the Investigator such as peripheral retina dystrophy are not exclusionary.
  5. Intraocular surgery (including lens replacement surgery) within 3 months prior to enrollment.
  6. History of laser therapy in the macular region.
  7. History of intraocular injection within 3 months prior to screening.
  8. Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
  9. Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
  10. Any contraindication to IVT injection including current ocular or periocular infection.
  11. Participation in any systemic experimental treatment or any other systemic investigational new drug including within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
  12. Medical or psychiatric conditions that, in the opinion of the Investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
  13. Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
  14. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.

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): NCT03777332


Locations
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United States, California
Apellis Clinical Site
Bakersfield, California, United States, 93309
Apellis Clinical Site
Beverly Hills, California, United States, 90211
United States, Massachusetts
Apellis Clinical Site
Boston, Massachusetts, United States, 02114
United States, Texas
Apellis Clinical Site
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.

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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03777332     History of Changes
Other Study ID Numbers: APL2-103
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Geographic Atrophy
Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases