| CTRI Number |
CTRI/2021/10/037507 [Registered on: 22/10/2021] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to compare the safety and effectiveness of study drug (OPT-302) in combination with aflibercept, compared with aflibercept alone who have age related loss of vision in the central part of their eye. |
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Scientific Title of Study
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A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
|
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Secondary IDs if Any
|
| Secondary ID |
Registry |
| 2020-004694-46 |
EudraCT |
| OPT-302-1005 Version: 1.0 Dated 16th December 2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Address |
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| Phone |
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| Fax |
|
| Email |
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Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Bhawana Awasthy |
| Address |
InVentiv International Pharma Services Private Limited (Syneos Health), 4th Floor, Block-2, DLF Downtown, Commercial Site, Block-V, DLF City, Phase III, Sector-25A, Gurugram – 122002
Gurgaon
HARYANA
122002
India |
| Phone |
9560692103 |
| Fax |
|
| Email |
bhawana.awasthy@syneoshealth.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Ataur Rahman |
| Address |
InVentiv International Pharma Services Private Limited (Syneos Health), 4th Floor, Block-2, DLF Downtown, Commercial Site, Block-V, DLF City, Phase III, Sector-25A, Gurugram
Gurgaon
HARYANA
122002
India |
| Phone |
8532011805 |
| Fax |
|
| Email |
ataur.rahman@syneoshealth.com |
|
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Source of Monetary or Material Support
|
| Opthea Limited, 650 Chapel Street, South Yarra, VIC 3141, Australia |
|
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Primary Sponsor
|
| Name |
Opthea Limited |
| Address |
650 Chapel Street, South Yarra, VIC 3141, Australia |
| Type of Sponsor |
Other [Public Biotechnology company] |
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Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| inVentiv International Pharma Services Private Limited |
4th Floor, Block-2, DLF Downtown, Commercial Site, Block-V, DLF City, Phase III, Sector-25A, Gurugram – 122002
|
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Countries of Recruitment
|
Argentina
Australia
Austria
Brazil
Bulgaria
Canada
Colombia
Croatia
Czech Republic
Denmark
Estonia
France
Germany
Greece
Hungary
India
Israel
Italy
Latvia
Lithuania
Netherlands
Philippines
Poland
Republic of Korea
Slovakia
Spain
Taiwan
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Sanjay Laul |
Chopda Medicare & Research Centre Pvt. Ltd Magnum Heart Institute |
3/5 Patil Lane No. 1, Laxmi Nagar,Near K.B.H Vidyalaya, Canada Corner, Nashik-422005, Maharashtra.
Nashik
|
9656442160
drlaulrs@gmail.com |
| Dr Brijesh Takkar |
L V Prasad Eye Institute |
Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Hyderabad-500034
Hyderabad
|
9868092215
Brijeshtakkar@lvpei.org |
| Dr Tapas Ranjan Padhi |
L V Prasad Eye Institute |
Mithu Tulsi Chanrai Campus, Patia, Bhubhaneswar-751024, Odisha
Cuttack
|
9438361078
tapas@lvpei.org |
| Dr Satish K |
Mysore Medical College and Research Institute |
K.R. Hospital, Irwin Road, Mysuru- 570001, Karnataka
Mysore
|
9886400414
drsatishkeshav@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -MMC and RI and Associated Hospital Mysore Medical College and Research Institute, Care Hospital, Irwin Road, Mysuru- 570001, Karnataka |
Approved |
| Institutional Ethics Committee L V Prasad Eye Institute, Mithu Tulsi Chanrai Campus, Patia, Bhubhaneswar-751024, Odisha. |
Submittted/Under Review |
| L V Prasad Eye Institute Ethics Committee L V Prasad Eye Institute, Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Hyderabad-500034. |
Approved |
| Magna-Care Ethics Committee Magnum Heart Institute, 3/5 Patil Lane No. 1, Laxmi Nagar, Near K.B.H Vidyalaya, Canada Corner, Nashik-422005, Maharashtra. |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neovascular age-related macular degeneration |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
|
Biological: 2.0 mg OPT-302
intravitreal injection
Biological: 2.0 aflibercept
intravitreal injection
|
| Intervention |
Experimental: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
|
Biological: 2.0 mg OPT-302
intravitreal injection
Biological: 2.0 aflibercept
intravitreal injection
|
| Comparator Agent |
Sham Comparator: 2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
Sham intravitreal injection administered at 4-weekly intervals
|
Biological: 2.0 aflibercept
intravitreal injection
Procedure: Sham
intravitreal injection
|
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Inclusion Criteria
Modification(s)
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
• Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
• An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
Main Exclusion Criteria:
• Any previous treatment for neovascular AMD.
• Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
• Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
|
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| ExclusionCriteria |
| Details |
Main Exclusion Criteria:
• Any previous treatment for neovascular AMD.
• Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
• Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
| Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters |
Baseline to Week 52 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters 2.Proportion of participants gaining 15 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters 3.Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) 4.Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) 5.Change in central subfield thickness (CST) by spectral domain optical coherence tomography (SD-OCT) 6.Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function.
|
[ Time Frame: Baseline to Week 52] |
|
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Target Sample Size
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Total Sample Size="990"
Sample Size from India="47" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
30/10/2021 |
| Date of First Enrollment (Global) |
09/04/2021 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NIL |
Brief Summary
Modification(s)
|
This study is a Phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked, superiority study of approximately 102 weeks in duration. Eligible study participants will be randomised at Baseline to one of three treatment arms in a 1:1:1 ratio: intravitreal aflibercept followed by Standard Dosing 2.0 mg OPT-302; intravitreal aflibercept followed by Extended Dosing 2.0 mg OPT-302; or intravitreal aflibercept followed by a sham injection. The study has two phases, the Efficacy Phase (Baseline to Week 52 [Visit 15]) and the Safety Phase (Week 52 to Week 100 [Visit 15 to Visit 27]). Although efficacy and safety will be assessed during both study phases, the efficacy of OPT-302 is intended to be characterised during the Efficacy Phase (via the primary and secondary efficacy endpoints), and the safety of OPT-302 after long term (2 year) administration is intended to be characterised during the Safety Phase. |
