| CTRI Number |
CTRI/2010/091/000257 [Registered on: 25/03/2010] |
| 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 |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function |
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Scientific Title of Study
|
A Multicenter, Masked, Randomized, Sham-Controlled, Parallel-Group, 3 Month Study with a 9-Month Safety Extension to Evaluate the Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS®) Applicator System in Improving Visual Function in Patients with a Previous Rhegmatogenous Macula-Off Retinal Detachment |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 190342-031D |
Protocol Number |
| NCT00972374 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Therapeutic Area Head Allergan, Inc |
| Designation |
|
| Affiliation |
|
| Address |
Clinical Research Director
Allergan Pharmaceutical Development Center
Bangalore
KARNATAKA
560 027
India |
| Phone |
91 80 40389500 |
| Fax |
|
| Email |
clinicaltrials@allergan.com |
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Details of Contact Person
Scientific Query
|
| Name |
Therapeutic Area Head Allergan, Inc |
| Designation |
|
| Affiliation |
|
| Address |
Clinical Research Director
Allergan Pharmaceutical Development Center
Bangalore
KARNATAKA
560 027
India |
| Phone |
91 80 40389500 |
| Fax |
|
| Email |
clinicaltrials@allergan.com |
|
Details of Contact Person
Public Query
|
| Name |
Therapeutic Area Head Allergan, Inc |
| Designation |
|
| Affiliation |
|
| Address |
Clinical Research Director
Allergan Pharmaceutical Development Center
Bangalore
KARNATAKA
560 027
India |
| Phone |
91 80 40389500 |
| Fax |
|
| Email |
clinicaltrials@allergan.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
|
| Name |
Allergan, Inc. |
| 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
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Kim Ramasamy |
Aravind Eye Hospital |
1 Anna Nagar,-625 020
Madurai
TAMIL NADU |
+91-452-4356100
kim@aravind.org |
| Dr. Madhusudhan Davda |
Bombay City Eye Institute and Research Centre |
5 Babulnath Road,-400 007
Mumbai
MAHARASHTRA |
+91-22-23671011
drmadhusudan13@gmail.com |
| Dr. Satpal Garg |
Dr. R.P. Centre for Ophthalmic Sciences |
All India Institute of Medical Sciences,-110 029
|
+91-452-4356100
dr_spgarg@yahoo.co.in |
| Dr. Lingam Gopal |
Sankara Nethralaya |
18 College Road,-600 006
Chennai
TAMIL NADU |
+91-044-28271616
drlg@snmail.org |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Aravind Eye Care System IRB, Aravind Eye Hospital |
Approved |
| Ethics Committee of Bombay City Eye Institute and Research Centre |
Approved |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
| Vision Research Foundation |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rhegmatogenous Macula-off Retinal Detachment, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system |
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at Day 1 in study eye |
| Intervention |
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system |
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at Day 1 in study eye |
| Comparator Agent |
Sham Posterior Segment Drug Delivery system |
Sham Posterior Segment Drug Delivery system
Applicator System at Day 1 in study eye (meaning no treatment) |
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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 |
- The macula-off retinal detachment must have been caused by a
rupture (rhegmatogenous in etiology)
- The repair of the macula-off retinal detachment must have
occurred at least 6 months before the Day 1 visit in the study eye
- The repair must have been deemed an anatomic success and
required no more than one macular re-attachment procedure
- The visual acuity score must be between 20/50 and 20/320 in the study eye |
|
| ExclusionCriteria |
| Details |
- Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
- Anticipated need for ocular surgery during the 12-month study
period
- Any injectable, periocular, or intravitreal corticosteroid treatment
to study eye within 6 months prior to screening (eg, triamcinolone
acetonide)
- Any injectable, periocular, or intravitreal anti-VEGF treatment to
the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
- Any infectious condition in the study eye |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Best Corrected Visual Acuity (BCVA) |
Month 3 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Mean BCVA change from baseline |
Month 3 |
|
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Target Sample Size
|
Total Sample Size="99"
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
|
Phase 2 |
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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) |
01/10/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study will evaluate the efficacy and safety of the Brimo PS DDS®
Applicator System (200 ug and 400 ug brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment. |