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Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated With Proton Therapy for a Large Choroidal Melanoma (PROTECT)

This study is not yet open for participant recruitment.
Verified May 2017 by Centre Hospitalier Universitaire de Nice
Sponsor:
ClinicalTrials.gov Identifier:
NCT03172299
First Posted: June 1, 2017
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose
The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation of the eyeball is sometimes necessary after proton therapy in the case of neovascular glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor) and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular glaucoma without avoiding enucleation in all cases. The investigators propose to study the prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.

Condition Intervention Phase
Ocular Melanoma Drug: Aflibercept Injection Drug: False injection Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-Vascular Endothelial Growth Factor in Patients Treated With Proton Therapy for a Large Choroidal Melanoma

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Occurrence of neovascular glaucoma [ Time Frame: at 5 years ]
    Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)


Estimated Enrollment: 56
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Injection of anti-VEGF Drug: Aflibercept Injection
Intravitreal injection of aflibercept 40mg/mL will be done on patients. The injections will be performed on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, injections will be performed every 3 months for a period of 21 months.
Placebo Comparator: false injection of anti-VEGF Drug: False injection
A false injection will be done on patients on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, falses injections will be performed every 3 months for a period of 21 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Choroid melanoma more than 7mm thick and / or over basal diameter of 15mm treated by proton therapy

Exclusion Criteria:

  • Iris melanoma
  • Melanoma immediately metastatic
  • Pregnant or breastfeeding women
  • Known hypersensitivity to aflibercept (anti-VEGF selected)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172299


Contacts
Contact: Stéphanie BAILLIF, Pr 492038025 ext +33 baillif.s@chu-nice.fr

Locations
France
CHU de Nice Not yet recruiting
Nice, France, 06003
Contact: Stéphanie BAILLIF, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Study Director: Stéphanie BAILLIF, Pr CHU de Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03172299     History of Changes
Other Study ID Numbers: 15-API-01
First Submitted: May 29, 2017
First Posted: June 1, 2017
Last Update Posted: June 7, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Melanoma
Glaucoma
Glaucoma, Neovascular
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Ocular Hypertension
Eye Diseases
Bevacizumab
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents