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Angiogenesis Inhibitor

OPT-302 + Ranibizumab for Age-Related Macular Degeneration (ShORe Trial)

Phase 3
Recruiting
Research Sponsored by Opthea Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
Any previous treatment for neovascular AMD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights

ShORe Trial Summary

This trial will compare the efficacy of a new treatment to a sham treatment over the course of 52 weeks.

Who is the study for?
This trial is for adults with active neovascular Age-related Macular Degeneration (nAMD) affecting the central part of their vision. Participants must have a certain level of visual acuity, measured by ETDRS BCVA score between 60 and 25 letters. Those with other significant eye disorders or conditions that could affect study participation or results are not eligible.Check my eligibility
What is being tested?
The study is testing the effectiveness of a new treatment called OPT-302 in combination with ranibizumab compared to ranibizumab alone, over two years. Patients will be randomly assigned to receive either both drugs or one drug plus a sham procedure, without knowing which group they're in.See study design
What are the potential side effects?
Possible side effects may include typical reactions related to eye injections such as eye pain, bleeding, inflammation, increased intraocular pressure, and potential impact on vision. The specific side effects of OPT-302 are not detailed but would be monitored closely.

ShORe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My eye condition is due to AMD and affects the center of my vision.
Select...
I have been treated for wet age-related macular degeneration before.
Select...
I do not have serious eye problems that could affect vision tests or safety assessments.
Select...
I'm sorry, but "Main" is not a clear or specific criterion. Could you please provide more context or information for me to accurately summarize it in plain language?

ShORe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
Secondary outcome measures
Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)
Proportion of participants gaining 10 more ETDRS BCVA letters
Proportion of participants gaining 15 or more ETDRS BCVA letters
+1 more

ShORe Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302Experimental Treatment2 Interventions
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
Group II: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302Experimental Treatment2 Interventions
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.
Group III: 0.5 mg ranibizumab with shamPlacebo Group2 Interventions
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.5 mg ranibizumab
2012
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Opthea LimitedLead Sponsor
4 Previous Clinical Trials
1,560 Total Patients Enrolled

Media Library

OPT-302 (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04757610 — Phase 3
Age-Related Macular Degeneration Research Study Groups: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302, 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302, 0.5 mg ranibizumab with sham
Age-Related Macular Degeneration Clinical Trial 2023: OPT-302 Highlights & Side Effects. Trial Name: NCT04757610 — Phase 3
OPT-302 (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04757610 — Phase 3
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT04757610 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any know risks associated with 0.5 mg ranibizumab?

"There is a fair amount of data, both anecdotal and clinical, that supports the safety of 0.5 mg ranibizumab which our team has rated as a 3."

Answered by AI

Are patients being enrolled in this experiment as we speak?

"The clinical trial is currently enrolling patients, with the first posting on March 12th, 2021 and the most recent update on September 6th, 2022."

Answered by AI

At how many different places can patients participate in this research?

"In total, there are 70 sites running this trial. This includes the ShORe Study Site in Towson, ShORe Investigational Site in Reno and ShORe Investigational site in Eugene."

Answered by AI

Is the dosage of .5mg ranibizumab common in other research?

"There are 33 clinical trials currently underway studying the effects of 0.5 mg ranibizumab. Of these, 16 are in Phase 3. Most trials for 0.5 mg ranibizumab are located near Oak Forest, Illinois; however, there are 941 research sites total in locations across the globe."

Answered by AI

What medical condition is 0.5 mg ranibizumab most effective against?

"0.5 mg ranibizumab is most commonly used for treatment of branch vein occlusion. It can also be prescribed to treat a variety of other conditions such as wet age-related macular degeneration (wamd), macular edema, myopic choroidal neovascularization."

Answered by AI

How many test subjects are enrolled in this experiment?

"In order to carry out this experiment, 990 people who meet the necessary requirements must be found. The sponsor, Opthea Limited, plans to do this from different locations - like ShORe Study Site in Towson, Maryland and ShORe Investigative Site in Reno, Nevada."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Ontario
Other
Florida
How old are they?
18 - 65
What site did they apply to?
ShORe Investigational Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

I wish to preserve existing vision. Would like to halt progression or even improve my vision.
PatientReceived 1 prior treatment
Just found out about macular degeneration from eye doctor. I have tried a sample drug and at tjis time it is too expensive for me.
PatientReceived 2+ prior treatments
I am interested in Laguna Hills not Fullerton too far . There is one in L.H. on your website.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screening tests take? What are my chances of getting selected?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
2021. "OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04757610.
All > Age Related Macular Degeneration > Wet Macular Degeneration
~272 spots leftby Jul 2025
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