A Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions/Small Choroidal Melanomas)

Conditions

Choroidal Melanoma

Brief summary

1. Incidence of AEs/SAEs., 2. Time to tumor progression.

Detailed description

1. Time to composite endpoint (tumor progression or vision loss of ≥15 letters), 2. Time to reach composite vision endpoint: visual acuity loss (≥15 letters) or initiation of vision-preserving/vision-correcting intervention., 3. Incidence of tumor progression over time., 4. Change from baseline in tumor thickness., 5. Change from baseline in LBD., 6. Tumor thickness growth rate., 7. Change in ETDRS-BCVA letter score., 8. Incidence of visual acuity loss of ≥15 letters., 9. Time to visual acuity loss of ≥15 letters., 10. Time to initiation of vision-preserving/vision-correcting intervention., 11. Incidence of radiation-associated complications., 12. Time to metastatic disease progression., 13. Overall survival.

Related papers

No related papers found yet.

Interventions

DRUGBELZUPACAP SAROTALOCAN

DRUGPlacebo (sham injection) to Belzupacap Sarotalocan solution for sham injection 0.0 mg/ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence of AEs/SAEs., 2. Time to tumor progression.	—

Secondary

Measure	Time frame
1. Time to composite endpoint (tumor progression or vision loss of ≥15 letters), 2. Time to reach composite vision endpoint: visual acuity loss (≥15 letters) or initiation of vision-preserving/vision-correcting intervention., 3. Incidence of tumor progression over time., 4. Change from baseline in tumor thickness., 5. Change from baseline in LBD., 6. Tumor thickness growth rate., 7. Change in ETDRS-BCVA letter score., 8. Incidence of visual acuity loss of ≥15 letters., 9. Time to visual acuity loss of ≥15 letters., 10. Time to initiation of vision-preserving/vision-correcting intervention., 11. Incidence of radiation-associated complications., 12. Time to metastatic disease progression., 13. Overall survival.	—

Measure

Time frame

1. Time to composite endpoint (tumor progression or vision loss of ≥15 letters), 2. Time to reach composite vision endpoint: visual acuity loss (≥15 letters) or initiation of vision-preserving/vision-correcting intervention., 3. Incidence of tumor progression over time., 4. Change from baseline in tumor thickness., 5. Change from baseline in LBD., 6. Tumor thickness growth rate., 7. Change in ETDRS-BCVA letter score., 8. Incidence of visual acuity loss of ≥15 letters., 9. Time to visual acuity loss of ≥15 letters., 10. Time to initiation of vision-preserving/vision-correcting intervention., 11. Incidence of radiation-associated complications., 12. Time to metastatic disease progression., 13. Overall survival.

—

Outcome results

None listed