| CTRI Number |
CTRI/2008/091/000087 [Registered on: 19/06/2008] |
| Last Modified On: |
05/08/2013 |
| 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
|
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2) |
|
Scientific Title of Study
|
A randomized, double masked, active controlled, phase 3 study of the efficacy, safety, and tolerability of repeated doses of intravitreal VEGF Trap-Eye in subjects with neovascular age-related macular degeneration (AMD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2007-000583-25 |
EudraCT |
| NCT00637377 |
ClinicalTrials.gov |
| Organisation ID:De-05113 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manish Garg |
| Designation |
|
| Affiliation |
Country Medical Director India |
| Address |
Bayer Pharmaceuticals Private Limited
Kolshet Road
Thane
MAHARASHTRA
400607
India |
| Phone |
02225311448 |
| Fax |
02225455080 |
| Email |
manish.garg@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manish Garg |
| Designation |
|
| Affiliation |
|
| Address |
Bayer Pharmaceuticals Private Limited
Kolshet Road
Thane
MAHARASHTRA
400607
India |
| Phone |
02225311448 |
| Fax |
02225455080 |
| Email |
manish.garg@bayer.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Bayer |
| Address |
Bayer Healthcare AG |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.S.Natarajan |
Aditya Jyot Eye Hospital |
Wadala,-400 031
Mumbai
MAHARASHTRA |
+91-22-24177600
+ 91-22-24177630
drdarshanag@yahoo.co.in |
| Dr.Amod Gupta |
Advance Eye Center |
PGIMR,-160012
Chandigarh
CHANDIGARH |
+91-172 -2747837
+91-172 -2747837
eyepgi@sify.com |
| Dr. Narendran VenKatapathy |
Aravind Eye Hospital |
Avinashi Road,-641014
Coimbatore
TAMIL NADU |
+91-422-5360400
+91-422-2593030
narendran@cbe.aravind.org |
| Dr.R.D Ravindran |
Aravind Eye Hospital |
Abhisega Pakkam Road,Tavalai Kuppam Junction, CuddaloreRoad-605007
Pondicherry
PONDICHERRY |
+91-413- 2619100
+91-413- 2618848
rdr@pondy.aravind.org |
| Dr.R.Kim |
Aravind Eye Hospital |
Anna Nagar,-625020
Madurai
TAMIL NADU |
+91-452-4356102
+91-452-2530984
kim@aravind.org |
| Dr. Manisha Agarwal |
Dr. Shroff?s Charity Eye Hospital |
5027, Kedar Nath Road, ,Daryaganj-110002.
New Delhi
DELHI |
011-43524444
011-43528816
sceh@sceh.net |
| Dr.S.P Garg |
Dr.R.P Center for Ophthalmic Sciences |
Ansari Nagar,AllMS-110029
New Delhi
DELHI |
+91-11-26589380
+91-11-26589380
dr_spgarg@yahoo.co.in |
| Dr. Raja Narayan |
L.V. Prasad Eye Institute |
L.V. Prasad Marg,Banjara Hills-500 034
Hyderabad
ANDHRA PRADESH |
+91-40-30612345
+ 91-40-23 548271
narayanan@lvpei.org |
| Dr. Tara Prasad Das |
L.V. Prasad Eye Institute |
,-
|
+91-674-3207018
+91-674-3987130
tpd@bei-lvpei.org |
| Dr.Thomas Cherian |
Little Flower Hospital Trust |
P.B No.-23,-683572
|
+91 484 2452546
+91 484 2452646
tcherian@rediffmail.com |
| Dr. Bhargava Natesh |
Narayana Netralaya |
121/C, Chord Road,Rajaji Nagar,1st R- Block-560010
Bangalore
KARNATAKA |
+91-80-23225102
+91-80-23377329
sribhargava.natesh@gmail.com |
| Dr.Himadri Datta |
Regional Institute Of Ophthalmlogy |
Medical College,88 college street-700073
Kolkata
WEST BENGAL |
+91-33-22190954
+91-33-22190954
himadreedatta@yahoo.com |
| Dr.Manish Nagpal |
Retina Foundation |
Near underbridge,Shahibag-380009
Ahmadabad
GUJARAT |
+91 79 65422199
+91 79 22866381
drmanishnagpal@yahoo.com |
| Dr. Rahul Ashok Shroff |
Shroff Eye Hospital |
222 S.V. Road,Bandra (west)-400050
Mumbai
MAHARASHTRA |
0222811863
0222812751
shroffeye@vsnl.com |
| Dr. Tarun Sharma |
Vision Research Foundation |
Shankar Netralaya 18,College Road-600 006
Chennai
TAMIL NADU |
+91-44- 28271616
+91-44- 28254180
dr.taruns@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Aditya Jyot Eye Hospital Ethics Committee, Wadala, Mumbai |
Approved |
| Ethics Committee, All India Institute of Medical Science, NewDelhi 110029 |
Approved |
| Ethics Committee, Little Flower Clinical Ethics Committee, Angamaly, Kerala |
Approved |
| Ethics Sub-Committee, Vision Research Foundation, Sankara Nethralaya, Chennai,600006 |
Approved |
| Institutional Ethics Committee, Narayana Nethralaya, Bangalore-560010 |
Approved |
| Institutional Ethics Committee, PostGraduate Institute of Medical Education & Research Chandigarh, India |
Approved |
| Institutional Ethics Committee,Regional Institute of Ophthalmology, Medical College & Hospital, Kolkata 700073 |
Approved |
| Institutional Review Board, Arvind Medical Research Foundation, Madurai 625020, Tamil Nadu for Dr. Narendran Venkatapathy |
Approved |
| Institutional Review Board, Arvind Medical Research Foundation, Madurai 625020, Tamil Nadu for Dr. R.D Ravindran |
Approved |
| Institutional Review Board, Arvind Medical Research Foundation, Madurai 625020, Tamil Nadu for Dr. R.Kim |
Approved |
| L.V. Prasad Eye Ethics Committee for Dr. Raja Narayanan |
Approved |
| L.V. Prasad Eye Ethics Committee for Dr. Tara Prasad Das |
Approved |
| Retina Foundation Institutional Review Board, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Macular Degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ranibizumab |
0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| Intervention |
VEGF Trap-Eye |
0.5 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks |
| Intervention |
VEGF Trap-Eye |
2.0 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| Intervention |
VEGF Trap-Eye |
2.0 mg VEGF Trap-Eye administered every 8 weeks (including one additional 2,0 mg dose at Week 4) during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
-Signed informed consent.
-Men and women ≥ 50 years of age.
-Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
-ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
-Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
-Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the
informed consent form. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
-Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
-Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
-Any prior treatment with anti-VEGF agents in the study eye.
-Total lesion size >12 disc areas (30.5 mm², including blood, scars and neovascularization) as assessed by FA in the study eye.
-Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the
fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
-Scar or fibrosis making up >50% of the total lesion in the study eye.
-Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
-History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
-Presence of other causes of CNV in the study eye.
-Prior vitrectomy in the study eye.
-History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
-Any history of macular hole of stage 2 and above in the study eye.
-Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
-History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart compared to baseline (ie, prevention of moderate vision loss) |
52 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in CNV area at Week 52 [ Time Frame: week 52 |
52 Weeks |
| The proportion of subjects who gain at least 15 letters of vision at Week 52 |
52 Weeks |
| Mean change from baseline in total NEI VFQ-25 score at Week 52 |
52 Weeks |
| Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 |
52 Weeks |
|
|
Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/01/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
(FPFV in India: 25.05.2008) |