Eye melanoma Eye cancer
Conditions
Interventions
Once eligibility is confirmed, qualified subjects will be randomly assigned to 
1 of 3 treatment arms
(80 µg bel-sar treatment arm, 40 µg bel-sar treatment arm, or sham control arm).
The bel-sar treatment arms will receive 3 cycles of treatment at the assigned 
dose and the sham control arm will receive 3 cycles of sham treatment. One cycle is defined as once/week treatment
(bel-sar and laser for the 2 bel-sar treatment arms or sham injection and sham 
laser for the sham control arm) administered for 3 consecutive weeks (e.g., Cycle 1 treatments will occur on Days 1, 8, and 15). Cycle 2 is planned to initiate at Week 4 and Cycle 3 at Week 8.
Sponsors
Aura Biosciences. Inc
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Ocular inclusion criteria apply to the study eye only unless specifically stated otherwise. Subject must: 1. Be at least 18 years of age. 2. Have been informed about the nature and requirements of the trial, voluntarily agreed to participate in the trial and follow all trial procedures and documented their consent by signing the Informed Consent Form before participating in any trial-related activities. 3. Have no evidence of metastatic disease confirmed per the SoC and at a minimum by abdominal and chest imaging within 2 months prior to enrollment. 4. Be treatment naïve for their IL/CM (Note: eligibility for subjects who have received treatment with photodynamic therapy >12 months prior to enrollment should be discussed with the medical monitor for approval prior to enrollment). 5. Have per the Investigator*s expert clinical judgment, a clinical diagnosis of primary IL/CM based on the clinical history, ophthalmic examination, FP and conventional ocular ultrasound for whom observation-only (i.e., a watchful waiting approach would be recommended standard of care.See protocol for all criteria
Exclusion criteria
Exclusion criteria: 1. Have in the Investigator's opinion, any active ocular infection or ocular disease in the study eye (other than IL/CM) that may progress during the trial and result in a change in vision, loss in vision, confound the trial assessments, or alter the SCS (e.g., clinically significant corneal dystrophies, keratoconus, glaucoma or clinically significant choroidal, retinal, macular, or scleral disease). Subjects who have a known history of steroid induced glaucoma or high myopia (>=-6.00 diopters) are also excluded. 2. Have an IL/CM that is in contact with the optic disc >=6 clock hours/>=180 degrees (based on true-color FP) per IRC or an IL/CM that invades the optic nerve per the Investigator's judgement. 3. Have evidence of extraocular extension or evidence of a break in Bruch's membrane (i.e., the tumor has spread outside the choroid) per the Investigator's judgment. 4. Have undergone any ocular surgical intervention in the study eye within 3 months before Visit 1 or are planning/will require ocular surgery in the study eye during the trial. Subjects who have had an uncomplicated minor procedure or cataract surgery within 1-3 months of Visit 1 should be discussed on a case-by-case basis with the medical monitor for approval prior to enrollment. Laser surgery (e.g., refractive laser surgery, argon laser trabeculoplasty/selective laser trabeculoplasty [ALT/SLT], and other minimally invasive surgeries [e.g., minimally invasive glaucoma surgery {MIGS}]) within 3 months of Visit 1 should be discussed with the medical monitor for approval prior to enrollment. 5. Have a history of any ocular surgery/procedure that could alter the SCS and affect SC administration of bel-sar (e.g., scleral buckle, laser retinopexy, macular laser, or pan-retinal photocoagulation). 6. Have an ETDRS-BCVA score worse than 65 letters in the study eye. 7. Use or require use of heparin or low molecular weight heparins within 1 week of any trial treatment or pentosan polysulfate within a year prior to Visit 1. 8. Use or requires use of immunosuppressive or antineoplastic medications within 5 half-lives of Visit 1. Steroids, including inhalation steroids, are permitted. 9. Any active malignancies other than IL/CM, or squamous or basal cell skin cancer. If there is evidence of clinical remission for at least 1 year, the subject's eligibility should be discussed with the medical monitor for approval prior to enrollment. 10. Have any significant illness (e.g., an uncontrolled autoimmune disease, liver disease, severe cardiovascular disease [confirmed by a cardiologist], active infection, etc.) or clinically significant laboratory abnormalities that the Investigator determines could interfere with trial participation or put the subject at any unnecessary risk. 11. Have used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another IP trial.12. Have known contraindications or sensitivities to phthalocyanine-based dye, the capsid component, or to prior treatment with laser.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to reach Tumor Progression (at the Week 65 analysis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary: *Time to reach Visual Acuity Failure 80 µg (at the Week 65 analysis). *Time to reach Tumor Progression 80 µg (at the Week 104 analysis). *Time to reach Visual Acuity Failure 80 µg (at the Week 104 analysis). *Time to reach the Composite Endpoint 80 µg (at the Week 104 analysis). *Time to reach Tumor Progression 40 µg (at the Week 65 analysis) | — |
Countries
Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, North-Korea
Contacts
Public ContactJ Hopkins
Aura Biosciences, Inc
Outcome results
None listed