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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02121353
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Pfenex, Inc

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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration (AMD) Drug: Lucentis Drug: PF582 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: PF582
PF582 is provided as single use vials and will be administered by intra‐vitreal injection on Day 1, 28 and 56.
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
Other Name: ranibizumab

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




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of PF582 [ Time Frame: Up to 12 months ]
    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.


Secondary Outcome Measures :
  1. To demonstrate the biosimiliarity between PF582 and Lucentis based on PK [ Time Frame: up to 12 months ]
    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.

  2. To demonstrate biosimilarity between PF582 and reference compound (Lucentis) [ Time Frame: 12 months ]
    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


Other Outcome Measures:
  1. To demonstrate the biosimiliarity between PF582 and the reference compound (Lucentis), based on pharmacodynamics (PD) parameters. [ Time Frame: Up to 12 months ]
    To demonstrate the biosimiliarity between PF582 and the reference compound (Lucentis), based on pharmacodynamics (PD) parameters. This will be assessed by measuring retinal thickness or central foveal thickness (CFT), assessed by optical coherence tomography (OCT)), Leakage from choroidal neovascularization (CNV) assessed by fluorescein angiography (FA).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121353


Locations
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New Zealand
Eye Institute
Remuera, Auckland, New Zealand, 1050
Auckland Eye 8 St Marks Road Remuera Auckland 1050
Auckland, New Zealand, 1050
Sponsors and Collaborators
Pfenex, Inc
Investigators
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Principal Investigator: Philip Polkinghorne, MD
Study Director: Hubert C Chen, MD Pfenex, Inc

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Responsible Party: Pfenex, Inc
ClinicalTrials.gov Identifier: NCT02121353    
Other Study ID Numbers: PF582-CLIN-001
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Pfenex, Inc:
Age related macular degeneration
AMD
Wet AMD
Eye conditions
CFT
OCT
CNV
FA
Ocular
Eye
Disorder of the eye
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents