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CompletedNCT03630562TARMAC-1Updated Mar 24, 2026

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

An interventional study of Aqueous humor samples collection in Age Related Macular Degeneration, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Age Related Macular Degeneration
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 100 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Other
    Patients with exudative AMD

    Procedure: Aqueous humor samples collection

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.

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What researchers measure

Primary outcomes

  1. Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months

    Time frame: At Month 3

Secondary outcomes

  1. Dose of VEGF in the aqueous humor of patients with exudative AMD

    Time frame: At Day 0, Month 1, Month 2, Month 3

  2. Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMD

    Time frame: At Day 0, Month 1, Month 2, Month 3

  3. Measurement of visual acuity with Snellen chart

    Time frame: At Day 0, Month 1, Month 2, Month 3

  4. Measurement of visual acuity with ETDRS visual acuity chart

    Time frame: At Day 0, Month 1, Month 2, Month 3

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Study locations

1 site
  • Hôpital Pasteur 2 - Service d'Ophtalmologie
    Nice, 06001, France
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References and documents

Publications

  • Lopez-Cazaux S, Aiem E, Velly AM, Muller-Bolla M. Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial. Trials. 2019 Aug 24;20(1):530. doi: 10.1186/s13063-019-3559-1. PubMed 31445509 ↗
  • Baillif S, Nahon-Esteve S, Pace-Loscos T, Pages G, Dufies M. Aqueous humor mediator levels as biomarkers of anti-VEGF response in age-related macular degeneration. Cytokine. 2025 Jun;190:156921. doi: 10.1016/j.cyto.2025.156921. Epub 2025 Mar 26. PubMed 40147376 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03630562
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Aug 15, 2018
Start date
Nov 26, 2018
Primary completion
Jan 12, 2021
Completion
Aug 19, 2021
Last update
Mar 24, 2026

Study contacts

Prof. Stéphanie BAILLIF, MD, PhD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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