| CTRI Number |
CTRI/2010/091/000379 [Registered on: 29/04/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
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A study to evaluate the effect of Lucentis® (Ranibizumab) on Vision Related Function using the VFQ-25 questionnaire in patients with wet age-related macular degeneration (AMD) |
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Scientific Title of Study
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A study to evaluate the effect of Lucentis® (Ranibizumab) on Vision Related Function using the VFQ-25 questionnaire in patients with wet age-related macular degeneration (AMD) |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CRFB 002 AIN 01 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. R. H. Muljiani |
| Designation |
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| Affiliation |
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| Address |
1st floor, Aboobakar Building
Near Regal cinema, colaba causeway
Mumbai
MAHARASHTRA
400001
India |
| Phone |
022-66573290 |
| Fax |
|
| Email |
rahimmuljiani@hotmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Prashant Dongre |
| Designation |
|
| Affiliation |
|
| Address |
Sandoz House, 5th floor, Shivsagar Estate
Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958589 |
| Fax |
022-24954112 |
| Email |
prashant,dongre@novartis.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Prashant Dongre |
| Designation |
|
| Affiliation |
|
| Address |
Sandoz House, 5th floor, Shivsagar Estate
Dr. Annie Besant Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958589 |
| Fax |
022-24954112 |
| Email |
prashant,dongre@novartis.com |
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Source of Monetary or Material Support
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| Novartis health care private limited |
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Primary Sponsor
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| Name |
Novartis health care private limited |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. R. H. Muljiani |
Dr. Muljiani Clinic |
1st floor, Aboobakar Building,Near Regal cinema, colaba causeway-400001
Mumbai
MAHARASHTRA |
022-66573290
rahimmuljiani@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
age-related macular degeneration (AMD), |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
|
| Intervention |
RANIBIZUMAB |
0.5 mg(0.05 ml) intravitreal injection administered as 3 monthly loading doses and then on a Prn basis (as per requirement ) |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1.Diagnosed with choroidal neovascularization (CNV) secondary to (wet) AMD
2.Willing to provide informed consent (as per the local practices)
Patients may have received Lucentis monotherapy or combination therapy [with Visudyne® (verteporfin)]
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| ExclusionCriteria |
| Details |
1.Hypersensitivity to the active substance or to any of the excipients.
2.Patients with active or suspected ocular or periocular infections.
3.Patients with active intraocular inflammation.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Mean change from baseline in VFQ-25 subscale scores* at 3, 6 & 12 months
*VFQ 25 Subscales: Near Vision Activities, Distance Vision Activities, Colour Vision, Vision Specific Dependency, Vision Specific Social Function, Vision Specific Mental Health |
3, 6 and 12 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| ?Mean change from baseline in VFQ-25 subscale scores** at 3 , 6 & 12 months
?Mean change from baseline in VFQ-25 composite score at 3 , 6 & 12 months
?Proportion of patients who gain ≥ 0, 1, 2, 3 lines of visual acuity from baseline at months 3 ,6 & 12
?Proportion of patients who lose < 3 lines of visual acuity from baseline at months 3 , 6 & 12
?Mean change from baseline in VFQ-25 subscale scores* at 12 months
?Mean change from baseline in VFQ-25 subscale scores** at 12 months
?Mean change from baseline in VFQ-25 composite score at 12 months
|
3, 6 and 12 months |
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Target Sample Size
|
Total Sample Size="500"
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" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Multi-centre, open-label, non-comparative, prospective, observational, post marketing surveillance (PMS) study in a real practice setting, for evaluation of mean change in VFQ-25 subscale scores over 12 months, in patients with wet age-related macular degeneration (AMD) treated with Lucentis.The study population will consist of patients with neovascular (wet) age related macular degenaration (AMD). The primary outcome of this study is the Mean change from baseline in VFQ-25 subscale scores* at 3, 6 & 12 months |