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Transcript of example.com...NARAYANA NETHRALAYA your faith shall healyou Super Speciality Eye Hospital & Post...
NARAYANANETHRALAYA
your faith shall heal youSuper Speciality Eye Hospital &
Post Graduate Institute of Ophthalmology
Narayana Nethralaya Ethics Committee
24thMarch, 2010
To,
Dr. Naresh Kumar Yadav,Narayana Nethralaya,1211C,Chord Road,Rajajinagar, I 'R' Block,Bangalore - 560 010.
Subject: EC Approval for the conduction ofthe Study - VGFT-OD-0819.
Dear Dr. Naresh Kumar Yadav,
The Narayana Nethralaya Ethics Committee reviewed and discussed yourapplication to conduct the clinical trial entitled "A Double-Masked, Randomised, Controlled Phase 3 Studyof the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration ofVEGF Trap-Eye inSubjects with Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)', in the EthicsCommittee Meeting.
The following documents submitted, were reviewed and discussed:
• DCGI Approval Letter - dated 8th March, 2010.• Import License dated 4th March, 2010.
The following members were present at the meeting held on 23nl March, 2010 at 03:30 PM,Narayana Nethralaya, Auditorium, (B'lore):
1. Dr. Sreevatsa Chairman
2. Dr. Sribhargava Natesh Member-Secretary
3. Mr. N. Mahalinga Bhat Advocate
4. Dr. Ravindra. R. Battu Medical Director
5. Dr. Arun Samprathi Consultant Ophthalmologist
6. Dr. Manjunath MarasandraNN 1 :
121/C, Chord Road,Rajajinagar,1st 'R' Block,
Bangalore-560 010.Ph: 91-80-66121300-1305
Fax: 91-80- 23377329Mobile: 99025 46046 (Emergency only)
Consultant OphthalmologistNN 2:
Narayana Health City(Narayana Hrudayalaya Campus)
# 258/A, Bommasandra, Hosur RoadBangalore-560 099. INDIA.
Phone: 91-80-66660655-658Fax: 91-80-66660650
Mobile: 9902821128 (Emergency only)
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Email - [email protected]@gmail.com
Website - www.narayananethralaya.org_•.
NARAYANANETHRAlAYA
- your faith shall heal youSuper Speciality Eye Hospital &
Post Graduate Institute of Ophthalmology
7. Dr. Rajani Battu Consultant Ophthalmologist
8. Dr. Nagabhushana.T.K. Specialist in General Medicine
9. Dr. Keshav.M Consultant Dermatologist
10. Dr. Mahesh.M Consultant Dermatologist
11. Mrs. Vanaja Ramdev Social - Worker
12. Dr. Mathew Kurian Consultant Ophthalmologist
We approve the Study to be conducted in its present form.
The Narayana Nethralaya Institutional Ethics Committee expects to be informed about the progress
of the Study, any SAE occurring during the course ofthe Study, any changes in the protocol and patient
information/informed consent document and requires to be provided a copy of the final report.
Yours' Sincerely,
NN 1 :121/C, Chord Road,
Rajajinagar,1st 'R' Block,
Bangalore·560 010.Ph : 91·80·66121300·1305
Fax: 91·80· 23377329Mobile: 99025.46046 (Emergency only)
NN2 :Narayana Health City
(Narayana Hrudayalaya Campus)# 258/A, Bommasandra, Hosur Road
Bangalore·560 099. INDIA.Phone : 91·80·66660655·658
Fax: 91·80·66660650Mobile: 9902821128 (Emergency only)
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Email [email protected]@gmail.com
Website· www.narayananethralaya.org
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