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Phase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study). (MONET)

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
0.5 mg ranibizumab
3 mg PF-04523655
1 mg PF-04523655
Sponsored by
Quark Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring AMD Age Related Macular Degeneration Choroidal Neovascularization Monet

Eligibility Criteria

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

Inclusion Criteria:

  • Males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Active CNV is defined as any leakage detected on FFA or OCT. Note: Female subjects 50- 60 years of age must be amenorrheic for at least 2 years and have a serum FSH level within the laboratory reference range for postmenopausal women
  • The total area of CNV (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area.
  • The total lesion size ≤12 disc areas.
  • Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit.
  • Best corrected visual acuity score in the fellow eye of 20/400 or better (letter score of ≥19) at the Screening Visit. Note: Only one eye will be treated (study eye) through the duration of the study. In the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject. The non-study eye may be treated with an approved AMD therapy
  • Subject has retinal central subfield thickness ≥250µm measured using Stratus OCT.

Exclusion Criteria:

  • Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline
  • History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye
  • Previous participation in any studies with investigational drugs or treatments administered 1 month preceding Baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), anti-angiogenic drugs such as pegaptanib (Macugen), ranibizumab (Lucentis), bevacizumab (Avastin) in the study eye
  • Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size
  • CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia
  • Presence of subfoveal scarring
  • Retinal pigment epithelial tear involving the macula in the study eye

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1 ranibizumab

Arm 2 ranibizumab and PF-04523655

Arm 3 ranibizumab and PF-04523655

Arm 4 ranibizumab and PF-04523655

Arm 5 ranibizumab and PF-04523655

Arm Description

0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12

0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg PF-04523655 given by intravitreal injection every 2 weeks from Week 4 to Week 12

0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg PF-04523655 given by intravitreal injection evey 4 weeks to Week 12

0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg of PF-04523655 given by intravitreal injection every 4 weeks from Week 4 to Week 12

0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg of PF-04523655 (30 minutes later) given in combination every 4 weeks from baseline to Week 12

Outcomes

Primary Outcome Measures

Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16

Secondary Outcome Measures

Percent of subjects gaining >/=15 letters in the best corrected visual acuity score at 16 weeks compared to Baseline, as measured using the ETDRS protocol
Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol
Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported
Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT
Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported
Change from Baseline in lesion size on FFA at Week 16

Full Information

First Posted
July 7, 2008
Last Updated
October 10, 2012
Sponsor
Quark Pharmaceuticals
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00713518
Brief Title
Phase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study).
Acronym
MONET
Official Title
Phase II Open Label Multicenter, Prospective, Randomized, Age Related Macular Degeneration, Comparator Controlled Study Evaluating PF-04523655 Versus Ranibizumab In The Treatment Of Subjects With Choroidal Neovascularization (MONET Study).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quark Pharmaceuticals
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
AMD Age Related Macular Degeneration Choroidal Neovascularization Monet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 ranibizumab
Arm Type
Active Comparator
Arm Description
0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12
Arm Title
Arm 2 ranibizumab and PF-04523655
Arm Type
Experimental
Arm Description
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg PF-04523655 given by intravitreal injection every 2 weeks from Week 4 to Week 12
Arm Title
Arm 3 ranibizumab and PF-04523655
Arm Type
Experimental
Arm Description
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg PF-04523655 given by intravitreal injection evey 4 weeks to Week 12
Arm Title
Arm 4 ranibizumab and PF-04523655
Arm Type
Experimental
Arm Description
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg of PF-04523655 given by intravitreal injection every 4 weeks from Week 4 to Week 12
Arm Title
Arm 5 ranibizumab and PF-04523655
Arm Type
Experimental
Arm Description
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg of PF-04523655 (30 minutes later) given in combination every 4 weeks from baseline to Week 12
Intervention Type
Drug
Intervention Name(s)
0.5 mg ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Type
Drug
Intervention Name(s)
3 mg PF-04523655
Intervention Type
Drug
Intervention Name(s)
1 mg PF-04523655
Primary Outcome Measure Information:
Title
Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percent of subjects gaining >/=15 letters in the best corrected visual acuity score at 16 weeks compared to Baseline, as measured using the ETDRS protocol
Time Frame
Week 16
Title
Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol
Time Frame
Week 16
Title
Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported
Time Frame
Week 48
Title
Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT
Time Frame
Week 16
Title
Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported
Time Frame
Week 48
Title
Change from Baseline in lesion size on FFA at Week 16
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Active CNV is defined as any leakage detected on FFA or OCT. Note: Female subjects 50- 60 years of age must be amenorrheic for at least 2 years and have a serum FSH level within the laboratory reference range for postmenopausal women The total area of CNV (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area. The total lesion size ≤12 disc areas. Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit. Best corrected visual acuity score in the fellow eye of 20/400 or better (letter score of ≥19) at the Screening Visit. Note: Only one eye will be treated (study eye) through the duration of the study. In the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject. The non-study eye may be treated with an approved AMD therapy Subject has retinal central subfield thickness ≥250µm measured using Stratus OCT. Exclusion Criteria: Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye Previous subfoveal focal laser photocoagulation in the study eye Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye Previous participation in any studies with investigational drugs or treatments administered 1 month preceding Baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), anti-angiogenic drugs such as pegaptanib (Macugen), ranibizumab (Lucentis), bevacizumab (Avastin) in the study eye Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia Presence of subfoveal scarring Retinal pigment epithelial tear involving the macula in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Pfizer Investigational Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Pfizer Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Linz
ZIP/Postal Code
A-4021
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
A-1030
Country
Austria
Facility Name
Pfizer Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 004
Country
India
Facility Name
Pfizer Investigational Site
City
Navrangpura, Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
Pfizer Investigational Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641014
Country
India
Facility Name
Pfizer Investigational Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Pfizer Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Pfizer Investigational Site
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Pfizer Investigational Site
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon City
ZIP/Postal Code
1113
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Alicante
ZIP/Postal Code
03016
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0451001&StudyName=Phase%20II%20Open%20Label%20Multicenter%20Study%20For%20Age%20Related%20Macular%20Degeneration%20Comparing%20An%20Investigational%20Drug%20PF-04523655%20Versus%20Lucentis%20I
Description
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Learn more about this trial

Phase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study).

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