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Study of of APL-2 Therapy in Patients Geographic Atrophy (FILLY)

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: NCT02503332
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 14, 2015
First Posted Date  ICMJE July 20, 2015
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date January 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
  • Primary Efficacy Endpoint: The primary endpoint is the change in square root geographic atrophy (GA) lesion size from baseline at month 12 as measured by FAF. [ Time Frame: 12 months from baseline ]
  • Primary Safety Endpoint: Number of local and systemic treatment emergent averse events (TEAE). [ Time Frame: 12 months from baseline ]
  • Primary Safety Endpoint: Severity of local and systemic treatment emergent averse events (TEAE). [ Time Frame: 12 months from baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of of APL-2 Therapy in Patients Geographic Atrophy
Official Title  ICMJE A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients Geographic Atrophy (GA)
Brief Summary The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
Detailed Description

This is a Phase II, prospective, multicenter, randomized, single-masked, sham-controlled study to assess the safety, tolerability and evidence of activity of multiple IVT injections of APL-2 in subjects with GA associated with Age-Related Macular Degeneration.

Patients diagnosed with GA associated with age-related macular degeneration in the study eye and who meet all inclusion/exclusion criteria will be included in the study. The study will randomize approximately 240 subjects to obtain at least 200 evaluable subjects across 40 multinational sites.

Subjects should be screened within 14 days before receiving APL-2. Upon entry into the study, subjects will be assigned a screening number. Patients who meet all inclusion and exclusion criteria and are confirmed as eligible by the CRC will return to the clinic for randomization and treatment on visit 2 (Day 0). At this visit, subjects will be randomized in a 2:2:1:1 manner to receive APL 2 Monthly (AM), APL-2 Every-Other-Month (AEOM), Sham injection Monthly (SM) or Sham injection Every-Other-Month (SEOM), respectively.

All subjects will return to the clinical site on Day 7 to assess acute safety after the first injection. After that, subjects in the monthly groups will return to the clinical site for additional APL-2 (or Sham) injections and study procedures every month until Month 12. Subjects in the Every-Other-Month groups will return to the clinical site for additional APL-2 (or Sham) injections and study procedures every two months until Month 12. All subjects will return for follow-up visits on Months 15 and 18 (3 and 6 months after last injection, respectively).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Geographic Atrophy
Intervention  ICMJE
  • Drug: APL-2
  • Other: Sham Procedure
Study Arms  ICMJE
  • Experimental: APL-2 15 mg/100 µL Monthly for 12 months
    A single dose of 15 mg APL-2/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injection every month for 12 consecutive months.
    Intervention: Drug: APL-2
  • Experimental: APL-2 15 mg/100 µL EOM for 12 months
    A single dose of 15 mg APL-2/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injections every other month (EOM) for 12 consecutive months.
    Intervention: Drug: APL-2
  • Sham Comparator: Sham Monthly for 12 months
    Subjects will receive a Sham procedure every month for 12 consecutive months.
    Intervention: Other: Sham Procedure
  • Sham Comparator: Sham EOM for 12 months
    Subjects will receive a Sham procedure every other month (EOM) for 12 consecutive months.
    Intervention: Other: Sham Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2015)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 11, 2018
Actual Primary Completion Date January 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Unless specified otherwise, ocular specific inclusion criteria apply to the study eye only.

  1. Male or Female.
  2. Age greater than of equal to 50 years.
  3. BCVA of 20/320 (Snellen equivalent) or better using ETDRS charts.
  4. Diagnosis of GA of the macula secondary to age-related macular degeneration, confirmed within 14 days prior to randomization by the central reading center (CRC) using Fundus Autofluorescence (FAF) images, as well as the following criteria:

    1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively), determined by screening images of FAF.
    2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA).
    3. GA can be completely visualized on the macula centered image.
    4. GA must be able to be photographed in its entirety.
    5. GA must be able to be measured separately from any areas of peripapillary atrophy as assessed by the CRC.
    6. Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautoflouorescence (i.e. pattern = none) is exclusionary. See Holz et al. 2007.1
  5. Female subjects must be:

    1. Women of non-child-bearing potential (WONCBP), or
    2. Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study.
  6. 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.
  7. Willing and able to give informed consent.

Exclusion Criteria: Unless specified otherwise, ocular specific inclusion criteria apply to the study eye only.

  1. GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy.
  2. Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
  3. Any history or current evidence of exudative ("wet") AMD including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere in the retina based on fluorescein angiogram as assessed by the CRC.
  4. Retinal disease other than AMD; however, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e. pavingstone degeneration).
  5. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination (e.g. advanced cataract or corneal abnormalities).
  6. Any ophthalmologic condition that prevents adequate imaging of the retina judged by the site or CRC.
  7. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
  8. Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to Day 0.
  9. Any ophthalmic condition that may require surgery during the study period.
  10. Any contraindication to IVT injection including current ocular or periocular infection.
  11. History of uveitis or endophthalmitis.
  12. History of IVT injection at any time.
  13. Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or 5 half-lives of the active (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.
  14. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the treatment period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.
  15. 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.
  16. Hypersensitivity to fluorescein.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02503332
Other Study ID Numbers  ICMJE POT-CP121614
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Apellis Pharmaceuticals, Inc.
Study Sponsor  ICMJE Apellis Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Federico Grossi, MD PhD Apellis Pharmaceuticals, Inc.
PRS Account Apellis Pharmaceuticals, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP