| CTRI Number |
CTRI/2010/091/000010 [Registered on: 09/03/2010] |
| Last Modified On: |
15/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of Central Retinal Vein Occlusion |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-Masked Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
Acronym COPERNICUS
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT01012973 |
ClinicalTrials.gov |
| VGFT-OD-0819 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Rahul Ashok Shroff |
| Designation |
|
| Affiliation |
|
| Address |
Shroff Eye Hospital & Vision Research Centre
222, S.V. Road, Bandra (West)
Mumbai
MAHARASHTRA
400 050
India |
| Phone |
09819421624 |
| Fax |
022-26550500 |
| Email |
rahul@shroffeye.org |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Rahul Ashok Shroff |
| Designation |
|
| Affiliation |
|
| Address |
Shroff Eye Hospital & Vision Research Centre
222, S.V. Road, Bandra (West)
Mumbai
MAHARASHTRA
400 050
India |
| Phone |
09819421624 |
| Fax |
022-26550500 |
| Email |
rahul@shroffeye.org |
|
Source of Monetary or Material Support
Modification(s)
|
| Regeneron Pharmaceuticals, Inc. |
|
Primary Sponsor
Modification(s)
|
| Name |
Regeneron Pharmaceuticals Inc |
| Address |
777 Old Saw Mill River RoadTarrytown, New York 10591, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| PAREXEL International Clinical Research Private Limited |
Plot # 180, 3rd Floor, MFAR Silverline Tech Park, EPIP II Phase, Whitefield, Bangalore – 560066, Karnataka, India.
Phone: 08040658100
Fax: 08040956536 |
|
Countries of Recruitment
Modification(s)
|
India
Argentina
Canada
Colombia
Israel
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. S. Natarajan |
Aditya Jyot Eye Hospital Pvt Ltd |
Plot No 153, Off Major Parmeshwaran Road,Opp. SIWS College, Wadala (W)-400 058
Mumbai
MAHARASHTRA |
022-24177600
022-241776600
natyforu@yahoo.co.in |
| Dr. Kim Ramasamy |
Aravind Eye Hospital |
1, Anna Nagar,-625 020
Madurai
TAMIL NADU |
0452-4356100
0452-2530984
kim@aravind.org |
| Dr. Venkatapathy Narendran |
Aravind Eye Hospital |
Avinashi Road,-641014
Coimbatore
TAMIL NADU |
0422-4360400
0422-2594344
narendran@cbe.aravind.org |
| Dr.Pankaja Dhoble |
Aravind Eye Hospital |
Cuddalore Main road,Thavalakuppam-605 007
Pondicherry
PONDICHERRY |
0413-2619100
0413-2618848
pankaja@pondy.aravind.org |
| Dr. Raja Narayanan |
L V Prasad Eye Institute |
Kallam Anji Reddy Campus, L V Prasad Marg,,Banjara Hills-500 034
Hyderabad
ANDHRA PRADESH |
040-30612618
040-23548271
: narayanan@lvpei.org |
| Dr. Taraprasad Das |
L V Prasad Eye Institute |
Patia,-752014
|
984 830 3571
0674-3987130
tpd@lvpei.org |
| Dr. Thomas Cherian |
Little Flower Hospital And Research Centre |
Post Box 23, Angamaly,-683572
|
0484 - 2452546
0484-2453223
tcherian@rediffmail.com |
| Dr. Naresh Kumar Yadav |
Narayana Nethralaya |
121/C, Chord Road, 1st ?R? Block, Rajaji Nagar, ,-560010
Bangalore
KARNATAKA |
080-23572633
080-23572633
vasudha.naresh@gmail.com |
| Dr. Himadri Datta |
Regional Institute of Ophthalmology |
88,College Street,-700 073
Kolkata
WEST BENGAL |
9830127929
033-22190954
himadri.datta@gmail.com |
| Dr. Rahul Ashok Shroff |
Shroff Eye Hospital & Vision Research Centre |
222, S.V. Road, Bandra (West),-400 050
Mumbai
MAHARASHTRA |
9819421624
022-26550500
rahul@shroffeye.org |
| Dr.Tarun Sharma |
Vision Research Foundation (Sankara Nethralaya) |
18 College Road, ,- 600 006
Chennai
TAMIL NADU |
9884267349
044-42137924
drtaruns@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethical Committee, Regional Institute of Opthalmology |
Approved |
| Ethics Committee, Aravind Eye Hospital - Coimbatore |
Approved |
| Ethics Committee, Aravind Eye Hospital - Madurai |
Approved |
| Ethics Committee, Aravind Eye Hospital - Pondycherry |
Approved |
| Ethics Committee, Hyderabad Eye Research Foundation, L V Prasad Eye Institute - Hyderabad |
Approved |
| Ethics Committee, Hyderabad Eye Research Foundation, L V Prasad Eye Institute. - Bhubaneshwar |
Approved |
| Ethics Committee, Shroff eye hospital |
Approved |
| Ethics Committee, Vision Research Foundation |
Approved |
| Institutional Ethics Committee, Aditya jyot eye hospital Pvt. Ltd. |
Approved |
| Institutional Ethics Committee, Little Flower Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, Narayana Netralaya |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Intraviteal injection of VEGF trap eye using standard techniques. |
The injection volume will be 50 µL (0.05 cc) for the 2 mg dose of VEGF Trap-Eye. |
| Comparator Agent |
Sham injection will be performed by pressing a syringe barrel with no active drug to the conjunctival surface. This will be done without a needle attached and without intraocular penetration. |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1. Center-involved macular edema secondary to CRVO with mean retinal thickness ≥ 250 μm in the central subfield on OCT
2. Adults ≥ 18 years
3. ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye
4. Men and women of childbearing potential must be willing to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly.
5. Willing, committed, and able to return for ALL clinic visits and complete all studyrelated procedures
6. Willingness to provide written informed consent |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. History of vitreoretinal surgery in the study eye or anticipated within the next 12 months following Day 1
2. Prior episode or bilateral manifestation of RVO
3. History of radial optic neurotomy or sheathotomy
4. Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
5. CRVO disease duration > 9 months from date of diagnosis
6. Decrease in visual acuity due to causes other than CRVO
7. Only one functional eye even if that eye is otherwise eligible for the study
8. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
9. History or presence of AMD (dry or wet form) that is considered by the investigator to significantly affect central vision, DME, or diabetic retinopathy, defined as eyes of diabetic subjects with more than one microaneurysm outside the area of the vein occlusion (inclusive of both eyes)
10. Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
11. Previous use of intraocular or periocular corticosteroids in the fellow eye within the 3 months prior to Day 1
12. Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.)
13. Previous treatment with anti-angiogenic drugs in the fellow eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within the 3 months prior to Day 1
14. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
15. Vitreomacular traction or epiretinal membrane in either the study eye or fellow eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision
16. Ocular inflammation (including trace or above) or external ocular inflammation in the study eye
17. History of idiopathic or autoimmune uveitis in either eye
18. Structural damage to the center of the macula in either the study eye or fellow eye that is likely to preclude improvement in VA following the resolution of macular edema
19. Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period
20. Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 3 months prior to Day 1 |
|
Method of Generating Random Sequence
Modification(s)
|
Stratified randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary efficacy measure is improvement in visual acuity versus baseline after 6 months of treatment. |
Week 24 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. visual acuity
2. Retinal thickness by OCT
|
Week 24 |
| 3. Anterior segment neovascularization, neovascularization of the optic disc (NVD) or neovascularization of retina (NVE) requiring pan-retinal photocoagulation |
Week 24 |
| 4. Change from baseline in NEI VFQ-25 total score, distance activities, near activities and vision dependency subscales |
Week 24 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="165"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
13/04/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
08/07/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
A Randomized, Double-Masked, Controlled Phase 3 Study with the primary objective to assess the efficacy of intravitreally (IVT) administered VEGF Trap-Eye compared to standard of care (observation [sham]) on best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol in subjects with macular edema secondary to CRVO. The study?s primary end point will be evaluated at Week 24. Please note that approximately 24 subjects from India will be enrolled from 11 different sites. The enrolment start in India is anticipated for the 31st March 2010 after DCGI approval is granted. |