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).

NCT00713518

Last updated date
Study Location
Pfizer Investigational Site
San Francisco, California, 94143, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age Related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Age Related Macular DegenerationPhase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study).
NCT00713518
  1. San Francisco, California
  2. Fort Myers, Florida
  3. Winter Haven, Florida
  4. Augusta, Georgia
  5. Indianapolis, Indiana
  6. Cleveland, Ohio
  7. Austin, Texas
  8. Linz,
  9. Wien,
  10. Glostrup,
  11. Hong Kong,
  12. Ahmedabad, Gujarat
  13. Navrangpura, Ahmedabad, Gujarat
  14. Coimbatore, Tamil Nadu
  15. New Delhi,
  16. Kfar Saba,
  17. Petah Tikva,
  18. Tel Aviv,
  19. Tel Hashomer,
  20. Zerifin,
  21. Seoul,
  22. Seoul,
  23. Seoul,
  24. Makati City,
  25. Manila,
  26. Quezon City,
  27. Alicante,
  28. Barcelona,
  29. Valencia,
  30. Taipei,
  31. Ankara,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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).
Official Title  ICMJE 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).
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age Related Macular Degeneration
Intervention  ICMJE
  • Drug: 0.5 mg ranibizumab
    Other Name: Lucentis
  • Drug: 3 mg PF-04523655
  • Drug: 1 mg PF-04523655
Study Arms  ICMJE
  • Active Comparator: Arm 1 ranibizumab
    0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12
    Intervention: Drug: 0.5 mg ranibizumab
  • Experimental: Arm 2 ranibizumab and PF-04523655
    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
    Interventions:
    • Drug: 0.5 mg ranibizumab
    • Drug: 3 mg PF-04523655
  • Experimental: Arm 3 ranibizumab and PF-04523655
    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
    Interventions:
    • Drug: 0.5 mg ranibizumab
    • Drug: 1 mg PF-04523655
  • Experimental: Arm 4 ranibizumab and PF-04523655
    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
    Interventions:
    • Drug: 0.5 mg ranibizumab
    • Drug: 3 mg PF-04523655
  • Experimental: Arm 5 ranibizumab and PF-04523655
    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
    Interventions:
    • Drug: 0.5 mg ranibizumab
    • Drug: 1 mg PF-04523655
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2011)
152
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2008)
160
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Denmark,   Hong Kong,   India,   Israel,   Korea, Republic of,   Philippines,   Spain,   Taiwan,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00713518
Other Study ID Numbers  ICMJE B0451001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quark Pharmaceuticals
Study Sponsor  ICMJE Quark Pharmaceuticals
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Quark Pharmaceuticals
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP