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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04757610




Registration number
NCT04757610
Ethics application status
Date submitted
12/02/2021
Date registered
17/02/2021
Date last updated
28/03/2024

Titles & IDs
Public title
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
Scientific title
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
Secondary ID [1] 0 0
OPT-302-1004
Universal Trial Number (UTN)
Trial acronym
ShORe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 2.0 mg OPT-302
Other interventions - 0.5 mg ranibizumab
Treatment: Surgery - Sham

Experimental: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302 - 0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.

Experimental: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302 - 0.5 mg ranibizumab intravitreal injection administered at 4-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.

Sham Comparator: 0.5 mg ranibizumab with sham - 0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
Sham intravitreal injection administered at 4-weekly intervals.


Other interventions: 2.0 mg OPT-302
intravitreal injection

Other interventions: 0.5 mg ranibizumab
intravitreal injection

Treatment: Surgery: Sham
intravitreal injection
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Proportion of participants gaining 15 or more ETDRS BCVA letters
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Proportion of participants gaining 10 more ETDRS BCVA letters
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT
Timepoint [4] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
- 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
990
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
ShORe Investigational Site - Hurstville
Recruitment hospital [2] 0 0
ShORe Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2220 - Hurstville
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Opthea Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked
study. Primary efficacy will be determined at Week 52.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04757610
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Opthea Limited
Address 0 0
Country 0 0
Phone 0 0
+61 3 9826 0399
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04757610