| CTRI Number |
CTRI/2013/08/003933 [Registered on: 29/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
27/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A multicentre,open-label,prospective,observational study to evaluate effectiveness and safety of repeated intravitreal injections of Lucentis® in patients with wet age-related macular degeneration over a 12-month observational period in a real-world setting |
|
Scientific Title of Study
|
Utilizing Ranibizumab intravitreal Injection in a real world setting-A multicentre, open-label, prospective, observational study to evaluate effectiveness and safety of repeated intravitreal injections (IVI) of Lucentis® (ranibizumab) in patients with neovascular age-related macular degeneration (AMD) over a 12-month observational period in a real-world setting.
|
| Trial Acronym |
UNVEIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alay Banker |
| Designation |
Principal Investigator |
| Affiliation |
Bankers Retina Clinic and Laser Centre |
| Address |
5, Subhash Society,
Near Ishwar Bhavan,
Commerce college 6 road,
Navrangpura,
Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
|
| Fax |
|
| Email |
alay.banker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashray Naik |
| Designation |
Medical Advisor |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited
Sandoz House, 5th floor
Shivsagar Estate
Dr. Annie Besant Road,
Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
24958579 |
| Fax |
|
| Email |
ashray.naik@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashray Naik |
| Designation |
Medical Advisor |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited
Sandoz House, 5th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
24958579 |
| Fax |
|
| Email |
ashray.naik@novartis.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Novartis India Limited |
| Address |
Novartis India Limited
Sandoz House, 5th floor
Shivsagar Estate
Dr. Annie Besant Road
India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alay Banker |
Bankers Retina Clinic and Laser Centre |
5 Subhash Society
Behind Ishvar Bhuvan
Ahmedabad 380009
Gujarat, India.
Ahmadabad
GUJARAT |
91-79-26569457
alay.banker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients diagnosed with wet Age related Macular Degeneration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravitreal Ranibizumab |
0.05 ml Intravitreally,once a month for three months and then as when required on PRN basis upto one year |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
� Presence of exudative age-related macular degeneration.
� Patients for whome a therapy with Lucentis� is medically indicated.
� Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care.
|
|
| ExclusionCriteria |
| Details |
Any contra-indication according to local Summary of Product Characteristics or Prescribing Information (SmPC or PI) of Lucentis®. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Data of response of Ranibizumab un Indian patients with wet AMD |
At the end of three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of injections required for vision stability |
1 year |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/03/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
06/12/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the effectiveness of repeated IVI Lucentis® 0,5 mg in wet AMD defined as mean change in BCVA (Best Corrected Visual Acuity) from Baseline to Month 3 post initiation of Lucentis treatment. |