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Trial record 4 of 13 for:    Apellis

Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal APL-2 for Patients With Wet AMD (ASAP II)

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: NCT02461771
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Brief Summary:
The objective of this study is to provide initial safety, tolerability and pharmacokinetics information of intravitreal administration of APL-2 in order to support further development into larger Phase II studies for treatment of patients with AMD.

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: APL-2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal APL-2 Therapy for Neovascular Age-Related Macular Degeneration (AMD)
Study Start Date : January 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Arm Intervention/treatment
Experimental: APL-2 Cohort 1
4 mg of APL-2 100 μL IVT injection
Drug: APL-2
On treatment day, subjects will be administered a single 100 μL IVT injection of APL-2 at the dose corresponding to their treatment assignment.

Experimental: APL-2 Cohort 2
10 mg of APL-2 100 μL IVT injection
Drug: APL-2
On treatment day, subjects will be administered a single 100 μL IVT injection of APL-2 at the dose corresponding to their treatment assignment.

Experimental: APL-2 Cohort 3
20 mg of APL-2 100 μL IVT injection
Drug: APL-2
On treatment day, subjects will be administered a single 100 μL IVT injection of APL-2 at the dose corresponding to their treatment assignment.




Primary Outcome Measures :
  1. Number and severity of local and systemic adverse events. [ Time Frame: 0-90 Days ]

Secondary Outcome Measures :
  1. Exposure after single APL-2 intravitreal dose (AUC). [ Time Frame: 0-30 days ]
  2. Maximum observed serum concentration (Cmax). [ Time Frame: 0-30 days ]
  3. Time to maximum measured concentration (Tmax). [ Time Frame: 0-30 days ]
  4. Terminal serum elimination half-life (t1/2). [ Time Frame: 0-30 days ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female
  2. Age ≥ 50 years
  3. The presence of an active choroidal neovascular lesion secondary to AMD
  4. On treatment with anti-VEGF therapy (Lucentis®, Eylea® or Avastin®)
  5. Must have received at least 3 anti-VEGF treatments over the 26-week period prior to screening (Screening Visit)
  6. Evidence that the macular fluid has responded to anti-VEGF in the past based on OCT in the opinion of PI
  7. At screening, evidence of subretinal fluid and retinal cystic changes
  8. Must have received anti-VEGF treatment within 10 days prior to APL-2 treatment (anti-VEGF can be administered on the same day of the screening visit after the screening procedures have been completed)
  9. OCTs of sufficient quality to allow for the assessment of the central macular fluid can be obtained
  10. Female subjects must be:

    • Women of non-child-bearing potential (WONCBP), Or
    • 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
  11. 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
  12. Willing and able to give informed consent

Exclusion Criteria:

  1. Choroidal neovascularization associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc
  2. Decreased vision due to retinal disease not attributable to choroidal neovascularization, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy
  3. Additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy
  4. Decreased vision due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina
  5. Cataract surgery within three months of enrollment
  6. Presence of any hemorrhage
  7. History of treatment for CNV:

    1. Previous PDT treatment within 30 days prior to enrollment in the study
    2. Previous extrafoveal or juxtafoveal thermal laser photocoagulation within 30 days prior to enrollment in the study
  8. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization
  9. Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, end stage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections
  10. Hypersensitivity to fluorescein

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): NCT02461771


Locations
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United States, California
United States, California
Beverly Hills, California, United States, 90211
United States, Florida
Untied States, Florida
Miami, Florida, United States, 33196
United States, New Hampshire
United States, New Hampshire
Portsmouth, New Hampshire, United States, 03801
Australia, New South Wales
Australia, New South Wells
Parramatta, New South Wales, Australia, 21550
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
Investigators
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Study Director: Federico Grossi, MD PhD Apellis Pharmaceuticals, Inc.

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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02461771     History of Changes
Other Study ID Numbers: POT-CP043014
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016

Keywords provided by Apellis Pharmaceuticals, Inc.:
AMD
Wet AMD
Neovascular AMD

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases