~NARAYANANETHRALAYA

To,Dr. Naresh Kumar YadavPrincipal InvestigatorNarayana Netbralaya, 12l/C, Chord Road,Rajajinagar, Bangalore- 560010,Kamataka, India

May 26, 2012

-- your faith shall heal you --Super Speciality Eye Hospital &

Post Graduate Institute of Ophthalmology

NN·1 & NN·2

Ref: Study to observe the effectiveness and safety of ranibizumab through individualized patienttreatment and associated outcomes

Subject: Approval for the Study and the Study Submissions

Dear Dr. Naresh Kumar Yadav,

With reference to your Submission letter dated May 14, 2012 for the approval of Study and the Study documents,the Institutional Ethics Committee of Narayana Netbralaya, reviewed and discussed, the below mentioned list ofdocuments for the Clinical Trial on Friday, 25 May 2012.

We approve the below mentioned submitted study documents and the conduct of the trial in the presentedform.S.No. Name of the study documents Version number Version date1. Study Protocol with sizaature paee 1.1 10/Au2:/20102. Protocol Amendment with signature 01 14INov/2011

paee3. Luminous PIS-ICF-Englisb India Master Template 021Feb/2012

v 2.04. Luminous PIS-ICF-Hindi India Master Template 021Feb/2012

v2.05. Luminous PIS-ICF-Kannada India Master Template 021Feb/2012

v 2.06. Luminous PIS-ICF-Tamil India Master Template 021Feb/2012

v2.07. Luminous PIS .•ICF .•Telugu India Master Template 021Feb/2012

v2.08. Luminous PIS-ICF-Malayalam India Master Template 02IFeb/2012

v 2.09. Translation certificates Yes 30IMar/2012

10. Summary of Product Characteristics Yes(SmPC)

11. Case Report Forms 1.9 30/Janl2012

12. Visual Functioning Questionnaire-25 VFQ.S001_l

13. Insurance Certificate Yes 23/Jan/2012

14. Siened and dated CV of the PI Yes 19/Apr/2012

Confidential (EC ref. no.: C/2012105/1) Page 1of 2

NN·1; 121/C, Chord Road, Rajaji Nagar, 1st 'R' Block, Banqalore - 10 -INDIA, Tel: +91-80-66121300-1305,1400-1404, Fax: +91-80-23377329NN-2: Narayana Health City, # 258/A, Bommasandra, Hosur Road, Bangalore - 99 - INDIA, Tel: +91-80-66660655-0658, Fax: +91-80-66660650

NN·3: No. 37, Castle Street, Opp. Sacred Heart Church, Ashok Nagar, Bangalore - 25. INDIA, Tel: +91·80·66974000·4003, FAX: +91-80-66974005

E-mail -info@narayananethralaya.com.info@nnmail.org www.narayananethralaya.org _I

16. Site Agreement Draft (not signed)

Yes

20/Janl2012

Undertaking by Investigator

Yes

The following members were present at the meeting held on May 25, 2012 at Auditorium of Narayana Nethralaya at3.00 pm.

SI. Name ofthe EC Role Designation and Gender Affiliation toNo. member Qualification the InstitutionI Dr. Sreevatsa ChairmaniBasic Scientist PhD (Biological Science) Male No

2 Dr. Rajesh Sasikumar Member Secretary/ MBBS,MS, Clinical Male YesOphthalmologist Fellowship in Glaucoma

3 Mr. Mahalinga Bhat Member/Legal Advisor B.Sc,LLB. Male No

4 Dr. Rajani Battu Member/ Ophthalmologist MBBS FRCS,MS,FMRF Female Yes

5 Mrs. Lalitha Member/Social Diploma in Secretarial Female NoWorker/layperson Practice. Managing

TrusteelFounder -'Sampurna'- B'lore

6 Dr. Keshava.M Member/ Male YesDermatologist MBBS,DVD

7 Sri Bharatarasabha Member/Theologist PRO Head, ISKCON, Male NoDasa Bangalore

Please inform us in case any Serious Adverse Event is observed during the conduct of the study and also let us havea periodic report on the progress of the Study (as per the EC SOP). We also request you to kindly notify and/orsubmit to EC, ifthere is any new information in the ICFs, protocol amendments.

It is to be noted that neither you nor any of your proposed study team members were present during the decision-making procedures of the Ethics Committee.

Please note that the Ethics Committee is formed and operating in compliance with the ICH-GCP and localregulatory requirements.

Yours Sincerely

The ChairmanNarayana Nethralaya Ethics Committee

ChairmanNartyana Nethralaya Ethic,Committee

•• npfor.

Legal AdvisorNarayana Nethralaya Ethics Committee

O'~'1JU N 201'2..

MemberNarayana Nethra'aya Ethic. Ci)mmittH

Bang.'or.

'11'8 JUN 2012

Confidential (EC ref. no.: C/2012105/1) Page 2 of 2

NN-1; 121/C, Chord Road, Rajaji Nagar, 1st 'R' Block, Bangalore -10 -INDIA, Tel: +91-80-66121300-1305,1400-1404, Fax: +91-80-23377329NN-2: Narayana Health City, # 258/A, Bommasandra, Hosur Road, Bangalore - 99 - INDIA, Tel: +91-80-66660655-0658, Fax: +91-80-66660650

NN-3: No. 37, Castle Street, Opp. Sacred Heart Church, Ashok Nagar, Bangalore - 25. INDIA, Tel: +91-80-66974000 - 4003, FAX: +91-80-66974005

E-mail -info@narayananethralaya.com.info@nnmaiLorg www.narayananethralaya.org

_I