A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 3

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 of either sex or any race.
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)
could
be an appropriate standard of care.

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.
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.
9. 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.
10. 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.
11. Have known contraindications or sensitivities to phthalocyanine-based dye,
the capsid
component, or to prior treatment with laser.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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