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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

New Zealand

Study Type

Interventional

Intervention

Lucentis

PF582

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration (AMD) focused on measuring Age related macular degeneration, AMD, Wet AMD, Eye conditions, CFT, OCT, CNV, FA, Ocular, Eye, Disorder of the eye

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Eye Institute
Auckland Eye 8 St Marks Road Remuera Auckland 1050

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PF582

Lucentis

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT02121353

First Posted

April 17, 2014

Last Updated

May 9, 2016

Sponsor

Pfenex, Inc

1. Study Identification

Unique Protocol Identification Number

NCT02121353

Brief Title

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

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfenex, Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF582

Arm Type

Experimental

Arm Description

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

Arm Title

Lucentis

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lucentis

Other Intervention Name(s)

ranibizumab

Intervention Description

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

Intervention Name(s)

PF582

Other Intervention Name(s)

ranibizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

To evaluate the safety and tolerability of PF582

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.

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

To demonstrate the biosimiliarity between PF582 and Lucentis based on PK

Description

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.

Time Frame

up to 12 months

Title

To demonstrate biosimilarity between PF582 and reference compound (Lucentis)

Description

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

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

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

Description

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).

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Polkinghorne, MD

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hubert C Chen, MD

Organizational Affiliation

Pfenex, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Eye Institute

City

Remuera

State/Province

Auckland

ZIP/Postal Code

1050

Country

New Zealand

Facility Name

Auckland Eye 8 St Marks Road Remuera Auckland 1050

City

Auckland

ZIP/Postal Code

1050

Country

New Zealand

Age Related Macular Degeneration (AMD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial