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CTRI Number  CTRI/2009/091/000385 [Registered on: 24/06/2009]
Last Modified On: 06/02/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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)  
Scientific Title of Study
Modification(s)  
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). 
Secondary IDs if Any  
Secondary ID  Identifier 
B0451001  Protocol Number 
NCT00713518  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Swapnali Raut 
Designation  Compliance Oversight Lead 
Affiliation  Representing Pfizer Limited 
Address  Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India 
Phone  91-9821415224  
Fax  91-22-26525993  
Email  Swapnali.raut@pfizer.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Swapnali Raut 
Designation  Compliance Oversight Lead 
Affiliation  Representing Pfizer Limited 
Address  Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India 
Phone  91-9821415224  
Fax  91-22-26525993  
Email  Swapnali.raut@pfizer.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Swapnali Raut 
Designation  Compliance Oversight Lead 
Affiliation  Representing Pfizer Limited 
Address  Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India 
Phone  91-9821415224  
Fax  91-22-26525993  
Email  Swapnali.raut@pfizer.com  
 
Source of Monetary or Material Support  
Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102  
 
Primary Sponsor
Modification(s)  
Name  Pfizer Limited 
Address  Pfizer Limited, Patel Estate, off S. V. Road, Jogeshwari West, Mumbai - 400 102. India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nill   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Narendran Venkatapathy   Aravind Eye Hospital & Postgraduate Institute of Ophthalmology  Avinashi Road,-641014
Coimbatore
TAMIL NADU 
+91 0422 2594344
+91 0422 2594344
narendran@cbe.aravind.org 
Dr Alay Banker   Bankers Retina Clinic & Laser Centre  5- Subhash Society- Behind Ishwar Bhuvan- Near H L Commerce College six Roads- Navrangpura- Ahmedabad -380009- Gujarat
Ahmadabad
GUJARAT 
009179-6569457
XXXXXX-XXX5997
Alay.banker@gmail.com 
Dr. Yog Raj Sharma   Dr. Rajendra Prasad Centre for Ophthalmic Sciences  All India Institute of Medical Sciences,Ansari Nagar, Room number 486, 4th Floor-110029
New Delhi
DELHI 
+91 011-26593187
+91 011-26588919
yograjsharma@yahoo.com 
Dr. Manish Nagpal  Eye Research Center & Retina Foundation  Aso-Palov Eye Hospital, Near Shahibag Under Bridge,Rajbhavan Road-380 004
Ahmadabad
GUJARAT 
+91 079-22867982
+91 079-22866381
manishnagpal@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Retina Foundation Institutional Ethics committee  Approved 
Ethics Committee AIIMS  Approved 
Ethics Committee, Aravind Eye Hospital  Approved 
Independent Ethics Committee Aditya  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Age Related Macular Degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Arm 1: Active Comparator Intervention: Drug: Lucentis  Drug: Lucentis 0.5 mg intravitreal injection given every 4 weeks from baseline to Week 12  
Intervention  Arm 2: Experimental Intervention: Drug: PF-04523655  Drug: PF-04523655 0.5 mg of Lucentis given by intravitreal injection at baseline followed by 3 mg of PF-04523655 given every 2 weeks from Week 4 to Week 12  
Intervention  Arm 3: Experimental Intervention: Drug: PF-04523655  Drug: PF-04523655 0.5 mg of Lucentis given by intravitreal injection at baseline followed by 1 mg of PF-04523655 given from Week 4 to Week 12  
Intervention  Arm 4: Experimental Intervention: Drug: PF-04523655  Drug: PF-04523655 0.5 mg of Lucentis given at baseline by intravitreal injection followed by 3 mg of PF-04523655 given every 4 weeks from Week 4 to Week 12  
Intervention  Arm 5: Experimental Intervention: Drug: Combination  Drug: Combination 0.5 mg of Lucentis 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  
 
Inclusion Criteria
Modification(s)  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

1.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
2.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.
3 The total lesion size ≤12 disc areas.
4 Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit.
5 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
6. Subject has retinal central subfield thickness ≥250┬Ám measured using Stratus OCT.
 
 
ExclusionCriteria 
Details  1. Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye 2. Previous subfoveal focal laser photocoagulation in the study eye 3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline 4. History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye 5. 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 6. 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 7. CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia 8. Presence of subfoveal scarring 9. Retinal pigment epithelial tear involving the macula in the study eye  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at Week 16   Week 16  
 
Secondary Outcome  
Outcome  TimePoints 
5. Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported   week 48 
4. Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT   week 16 
3. Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported  week 48 
2. Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol   Week 16 
1. 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   Week 16 
6. Change from Baseline in lesion size on FFA at Week 16   week 16 
 
Target Sample Size
Modification(s)  
Total Sample Size="150"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
22/04/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  01/11/2009 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None 
Brief Summary
Modification(s)  
Recruitment for this study has ended, with India recruiting 18 subjects. Please note that only INDIA will be selected while uploading the CTRI website since the website does not contain all the participating country options. study is completed. 
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