NL-OMON56767尚未招募3 期
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 - AU-011-301-MD2
Aura Biosciences, Inc0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •abdominal and chest imaging within 2 months prior to enrollment.
- •4. Be treatment naïve for their IL/CM (Note: eligibility for subjects who have
- •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
- •IL/CM based on the clinical history, ophthalmic examination, FP and conventional
- •ocular ultrasound for whom observation-only (i.e., a watchful waiting approach)
- •be an appropriate standard of care.
排除标准
- •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,
- •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
- •(based on true-color FP) per IRC or an IL/CM that invades the optic nerve per
- •Investigator's judgement.
- •3. Have evidence of extraocular extension or evidence of a break in Bruch's
- •(i.e., the tumor has spread outside the choroid) per the Investigator's
- •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
- •Subjects who have had an uncomplicated minor procedure or cataract surgery
- •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
- •surgeries [e.g., minimally invasive glaucoma surgery {MIGS}]) within 3 months
- •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
- •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
- •trial treatment or pentosan polysulfate within a year prior to Visit 1.
- •8. Use or requires use of immunosuppressive or antineoplastic medications
- •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,
- •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
- •11. Have known contraindications or sensitivities to phthalocyanine-based dye,
- 另有 1 项未显示
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