Safety Study of PF582 Versus Lucentis in Patients With Age Related Macular Degeneration

NCT02121353 | Completed Phase 1 DMC

• 1 other identifier: PF582-CLIN-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (2)

• To demonstrate the biosimiliarity between PF582 and Lucentis based on PK

  up to 12 months

• To demonstrate biosimilarity between PF582 and reference compound (Lucentis)

  12 months

Other Outcomes (1)

• To demonstrate the biosimiliarity between PF582 and the reference compound (Lucentis), based on pharmacodynamics (PD) parameters.

  Up to 12 months

Study Arms (2)

PF582

EXPERIMENTAL

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

Drug: PF582

Lucentis

ACTIVE COMPARATOR

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

Drug: Lucentis

Interventions

Lucentis DRUG

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

Also known as: ranibizumab

Lucentis

PF582 DRUG

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

Also known as: ranibizumab

PF582

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfenex, Inc: lead

Study Sites (2)

Eye Institute

Remuera, Auckland, 1050, New Zealand

Location

Auckland Eye 8 St Marks Road Remuera Auckland 1050

Auckland, 1050, New Zealand

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Philip Polkinghorne, MD

  PRINCIPAL INVESTIGATOR

• Hubert C Chen, MD

  Pfenex, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 23, 2014
• Study Start: November 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

NZ (2)