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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02121353




Registration number
NCT02121353
Ethics application status
Date submitted
17/04/2014
Date registered
23/04/2014
Date last updated
11/05/2016

Titles & IDs
Public title
Safety Study of PF582 Versus Lucentis in Patients With Age Related Macular Degeneration
Scientific title
A Pilot Phase 1/2, Double Blind, Parallel Group, Controlled Study of the Safety, Tolerability and Preliminary Efficacy Evaluation of Intravitreally Administered Pfenex Ranibizumab Biosimilar Versus Lucentis for the Treatment of Neovascular AMD
Secondary ID [1] 0 0
PF582-CLIN-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age Related Macular Degeneration (AMD) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lucentis
Treatment: Drugs - PF582

Experimental: PF582 - PF582 is provided as single use vials and will be administered by intra-vitreal injection on Day 1, 28 and 56.

Active Comparator: Lucentis - Lucentis® is provided as single use vials and will be administered by intra-vitreal injection on Day 1, 28 and 56.


Treatment: Drugs: Lucentis
Single-use 2 mL vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. Excipients: Alpha, alpha-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections Route of Administration: Intra-vitreal

Treatment: Drugs: PF582
Single-use 2 mL vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. Excipients: Alpha, alpha-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections Route of Administration: Intra-vitreal

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of PF582 - To evaluate the safety and tolerability of PF582, compared to that of Lucentis (registered trademark) in patients with neovascular AMD. This will be done by assessment of vital signs, physical examination, laboratory blood tests and adverse events. Possible adverse events include: eye irritation/discomfort, redness/itching eye, eye dryness, abnormal sensation in eye; lens clouding; pain/irritation at injection site; increased tear production; 'floaters'; sore throat, nasal congestion, headache, joint pain, flu, fatigue, breathlessness, dizziness, pale skin, anxiety, cough, nausea and allergic reactions. Because PF582 is very similar to Lucentis it is expected to have similar adverse effects.
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [1] 0 0
To demonstrate the biosimiliarity between PF582 and Lucentis based on PK - To demonstrate the biosimiliarity between PF582 and the reference compound (Lucentis) based on pharmacokinetics (PK). This will be done by collection and analysis of PK blood samples.
Timepoint [1] 0 0
up to 12 months
Secondary outcome [2] 0 0
To demonstrate biosimilarity between PF582 and reference compound (Lucentis) - Preliminary analysis of efficacy, as evaluated by mean change in visual acuity between baseline and Day 80 assessment, and proportion of patients with a change in visual acuity of 15 letters or more
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
- Age =50 years

- Presence in the study eye (one eye per patient) of previously untreated active
subfoveal CNV due to AMD, with presence of leakage, as seen on FA, and of fluid, as
seen on spectral-domain OCT, located either within or below the retina, or below the
retinal pigment epithelium

- Visual acuity between 20/25 and 20/320 being measured using the Early treatment
diabetic retinopathy study (ETDRS) protocol1 (chart at 4 meters) before pupil
dilation.

- Neovascularization, fluid, or haemorrhage under the fovea.

- Fibrosis < 50% of total lesion area

- At least 1 drusen (>63µm) in either eye or late AMD in fellow eye.

- Female subjects must be of non-childbearing potential, meeting at least one of the
following criteria:

- Amenorrheal for 12 months (Menopause confirmed by FSH and LH levels as defined by the
established reference ranges), or taking oral contraception for at least 3 months, or
surgically sterile for at least the past 3 months, or Receiving a stable dose of
implanted or injectable contraceptive for at least 3 months
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous treatment for CNV in study eye, including antivascular endothelial growth
factor(VEGF) medication

- Other progressive retinal disease in the study eye, or the non-study eye, likely to
compromise Visual Acuity assessment.

- Contraindications to injections with Lucentis®

- Sub-retineal Haemorrhage > 50% of lesion

- Fibrosis or retrofoveolar atrophy

- History of retrofoveolar laser photocoagulation

- Previous Lucentis® treatment

- Any other treatment (photocoagulation, phototherapy, radiotherapy, surgery,
thermotherapy) in the last 3 months

- Aphaky, vitrectomy

- Active or suspected ocular or periocular infection

- Active intraocular inflammation

- Active systemic infection

- History of stroke or congestive heart failure

- Any other clinical significant illness or abnormalities that would compromise the
safety of the participant

- Inability to comply with study or follow up procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfenex, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to test if PF582 (ranibizumab) is safe and similar to Lucentis
(ranibizumab). Participants will have a screening visit to check for eligibility. Eligible
participants will receive either PF582 or Lucentis, by injection into one eye on study Day 1,
28 and 56. Visits will be conducted on Day 2, 7, 14 80 and at 6 and 12 months. During the
study participants will undergo the following procedures: height, weight and vital signs
(blood pressure, pulse, temperature, breathing rate) measurement; medical and surgical
history and concomitant medications; adverse event monitoring; physical examinations; eye
tests (reading chart, measurement of retinal thickness [via pictures of the retina] and
examination of the eye's blood vessels, via pictures taken following injection of a dye into
the arm), blood collection and a urine pregnancy test, where applicable.
Trial website
https://clinicaltrials.gov/show/NCT02121353
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Polkinghorne, MD
Address 0 0
Pfenex, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications