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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02461771
Registration number
NCT02461771
Ethics application status
Date submitted
2/06/2015
Date registered
3/06/2015
Date last updated
6/10/2020
Titles & IDs
Public title
Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD
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Scientific title
Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal APL-2 Therapy for Neovascular Age-Related Macular Degeneration (AMD)
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Secondary ID [1]
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POT-CP043014
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Universal Trial Number (UTN)
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Trial acronym
ASAP II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-Related Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pegcetacoplan
Experimental: Pegcetacoplan Cohort 1 - 4 mg of pegcetacoplan 100 µL IVT injection
Experimental: Pegcetacoplan Cohort 2 - 10 mg of pegcetacoplan 100 µL IVT injection
Experimental: Pegcetacoplan Cohort 3 - 20 mg of pegcetacoplan 100 µL IVT injection
Treatment: Drugs: Pegcetacoplan
On treatment day, subjects will be administered a single 100 µL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects Who Experienced Ocular and Systemic Adverse Events (AEs), Including by Severity
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Assessment method [1]
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Safety was assessed throughout the study. A TEAE was defined as any AE that started on/after the IVT injection of pegcetacoplan.
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Timepoint [1]
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Day 1 to Day 113
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Primary outcome [2]
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Number of Dose Limiting Toxicities (DLTs)
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Assessment method [2]
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The occurrence of any of the following AEs were considered DLTs: intraocular inflammation (vitritis or uveitis), endophthalmitis, sustained elevation of intraocular pressure =30 millimeters (mm) of mercury, and/or sustained loss of visual acuity =15 letters not attributable to the injection procedure or progression of disease.
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Timepoint [2]
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Day 1 to Day 15
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Primary outcome [3]
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Median Area Under the Serum Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-t])
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Assessment method [3]
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The AUC(0-t) was measured using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. The median AUC(0-t) is presented for each cohort.
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Timepoint [3]
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Predose (screening), postdose Day 3 to Day 113
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Primary outcome [4]
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Median Dose Normalized AUC(0-t)
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Assessment method [4]
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The AUC(0-t) was measured using the linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing. The dose normalized AUC(0-t) was calculated for each subject by dividing the parameter by the subject's respective dose in milligrams. The median dose normalized AUC(0-t) is presented for each cohort.
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Timepoint [4]
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Predose (screening), postdose Day 3 to Day 113
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Primary outcome [5]
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Maximum Observed Serum Concentration (Cmax)
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Assessment method [5]
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The median Cmax is presented for each cohort.
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Timepoint [5]
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Predose (screening), postdose Day 3 to Day 113
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Primary outcome [6]
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Median Dose Normalized Cmax
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Assessment method [6]
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The dose normalized Cmax was calculated for each subject by dividing the parameter by the subject's respective dose in milligrams. The median dose normalized Cmax is presented for each cohort.
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Timepoint [6]
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Predose (screening), postdose Day 3 to Day 113
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Primary outcome [7]
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Median Time to the Maximum Measured Serum Concentration (Tmax)
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Assessment method [7]
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The median Tmax is presented for each cohort. If the maximum value occurred at more than 1 time point, Tmax was defined as the first time point with this value.
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Timepoint [7]
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Predose (screening), postdose Day 3 to Day 113
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Secondary outcome [1]
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Median Change From Baseline in Visual Acuity for the Study Eye
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Assessment method [1]
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Best Corrected Visual Acuity (BCVA) letter score was determined using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. The score ranges from 0 to 100 letters, lower number indicating reduced visual acuity; a positive value of change from baseline indicates visual acuity gain and a negative value indicates visual acuity loss.
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Timepoint [1]
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Day 1 to Day 113
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Secondary outcome [2]
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Median Change From Baseline in Central Retinal Thickness, Central Retinal Lesion Thickness and Central Subfield Thickness in the Study Eye
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Assessment method [2]
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Central retinal thickness, central retinal lesion thickness and central subfield thickness were determined using Spectral Domain Optical Coherence Tomography (SD-OCT).
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Timepoint [2]
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Day 1 to Day 113
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Secondary outcome [3]
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Median Change From Baseline in Macular Cube Volume in the Study Eye
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Assessment method [3]
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Macular cube volume was determined using SD-OCT.
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Timepoint [3]
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Day 1 to Day 113
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Eligibility
Key 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 pegcetacoplan 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
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/03/2016
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Sample size
Target
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Accrual to date
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Final
13
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Australia, New South Wells - Parramatta
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Recruitment postcode(s) [1]
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2150 - Parramatta
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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New Hampshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Apellis Pharmaceuticals, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to provide initial safety, tolerability and pharmacokinetics
information of intravitreal administration of pegcetacoplan in order to support further
development into larger Phase II studies for treatment of patients with AMD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02461771
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Federico Grossi, MD PhD
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Address
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Apellis Pharmaceuticals, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02461771
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