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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03630562
Acronym
TARMAC-1
Enrollment
100
Registered
2018-08-15
Start date
2018-11-26
Completion date
2021-08-19
Last updated
2026-03-24

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

Conditions

Age Related Macular Degeneration

Brief 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.

Interventions

PROCEDUREAqueous 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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 monthsAt Month 3

Secondary

MeasureTime frame
Dose of VEGF in the aqueous humor of patients with exudative AMDAt Day 0, Month 1, Month 2, Month 3
Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMDAt Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with Snellen chartAt Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with ETDRS visual acuity chartAt Day 0, Month 1, Month 2, Month 3

Countries

France

Contacts

PRINCIPAL_INVESTIGATORProf. Stéphanie BAILLIF, MD, PhD

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026