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

NCT ID: NCT02121353

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-01-31

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.

Conditions

Age Related Macular Degeneration (AMD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PF582

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

Group Type: EXPERIMENTAL

PF582

Intervention Type: 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

Lucentis

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

Group Type: ACTIVE_COMPARATOR

Lucentis

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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 Type: DRUG

Other Intervention Names

ranibizumab; ranibizumab

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfenex, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Polkinghorne, MD

Role: PRINCIPAL_INVESTIGATOR

Hubert C Chen, MD

Role: STUDY_DIRECTOR

Pfenex, Inc

Locations

Eye Institute

Remuera, Auckland, New Zealand

Auckland Eye 8 St Marks Road Remuera Auckland 1050

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

PF582-CLIN-001

Identifier Type: -

Identifier Source: org_study_id