Clinical trial NCT02121353: Safety Study of PF582 Versus Lucentis in Patients With Age Related Macular Degeneration
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Age Related Macular Degeneration (AMD)
Keywords: Age related macular degeneration
AMD
Wet AMD
Eye conditions
CFT
OCT
CNV
FA
Ocular
Eye
Disorder of the eye
Lead sponsor: Pfenex, Inc
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: To evaluate the safety and tolerability of PF582
timeFrame: Up to 12 months
Secondary outcomes:
measure: To demonstrate the biosimiliarity between PF582 and Lucentis based on PK
timeFrame: up to 12 months
measure: To demonstrate biosimilarity between PF582 and reference compound (Lucentis)
timeFrame: 12 months
Other outcomes:
measure: To demonstrate the biosimiliarity between PF582 and the reference compound (Lucentis), based on pharmacodynamics (PD) parameters.
timeFrame: Up to 12 months
Locations:
city: Remuera
country: New Zealand
facility: Eye Institute
state: Auckland
city: Auckland
country: New Zealand
facility: Auckland Eye 8 St Marks Road Remuera Auckland 1050
Study officials:
name: Philip Polkinghorne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pfenex, Inc
name: Hubert C Chen, MD
role: STUDY_DIRECTOR
References: