Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

Age Related Macular Degeneration Clinical Trial

— TARMAC-1  

Official title:

Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630562
• Other study ID #: 17-PP-18
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: August 19, 2021

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines.

The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 19, 2021
• Est. primary completion date: January 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Diagnosis of exudative age-related macular degeneration requiring intravitreal anti-VEGF treatment.

• Patient for whom the last intravitreal injection of anti-VEGF in the eye is strictly more than 3 months

• Signature of informed consent

• Affiliation to the French social security system

Exclusion Criteria:

• Pregnant or nursing patient (a urinary pregnancy test will be performed)

• Systemic treatment with anti-VEGF

• Intravitreal treatment with anti-VEGF for less than 3 months regardless of the treated eye.

• Retinal pathology that can modify the secretion of pro-inflammatory cytokines such as diabetic retinopathy, venous occlusions, intermediate and posterior uveitis.

• Diabetes Mellitus

• High Myopia

• Simultaneous participation in another clinical research protocol in exudative AMD

• Person under guardianship, under curatorship, deprived of liberty

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Procedure:
• Aqueous humor samples collection
In addition to the routine examinations performed as part of the usual care of AMD patients, an anterior chamber puncture will be performed to collect the aqueous humor samples.

Locations

Country	Name	City	State
France	Hôpital Pasteur 2 - Service d'Ophtalmologie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months		At Month 3
Secondary	Dose of VEGF in the aqueous humor of patients with exudative AMD		At Day 0, Month 1, Month 2, Month 3
Secondary	Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMD		At Day 0, Month 1, Month 2, Month 3
Secondary	Measurement of visual acuity with Snellen chart		At Day 0, Month 1, Month 2, Month 3
Secondary	Measurement of visual acuity with ETDRS visual acuity chart		At Day 0, Month 1, Month 2, Month 3