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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

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

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

NCT ID

NCT00713518

First Posted

July 7, 2008

Last Updated

October 10, 2012

Sponsor

Quark Pharmaceuticals

Collaborators

Pfizer

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

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

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

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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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)

Age Related Macular Degeneration

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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