Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02874040

Enrollment

Registered

2016-08-22

Start date

2013-04-19

Completion date

2024-10-24

Last updated

2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Uveal, Uveal Melanoma

Brief summary

Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation

Interventions

PROCEDUREEndoresection

Endoresection of the tumor scar

PROCEDURELaser diode

Transpupillary thermotherapy by laser diode on the tumor scar

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Tumor of 7 mm of thickness or more * Patients treated by proton beam therapy * Patients aged at least 18 years * Patients clearly informed of the study, having received the letter of information and signed the consent

Exclusion criteria

* Massive extrascleral extension posterior to the equator * Patients with metastasis at diagnosis. * Patients with glaucoma before the radiation therapy * Patients with opaque media preventing transpupillary thermotherapy * Patients for whom follow up will be difficult due to geographical, social or psychological reasons

Design outcomes

Primary

Measure	Time frame	Description
Post-treatment complication incidence.	3 years	observed complications are : Number of glaucomas, numbrer of retinal detachment and number of secondary enucleations.

Secondary

Measure	Time frame
Measure of tumor scar thickness	3 years
Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale	3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026