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Completed

NCT Number: NCT03630562

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

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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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pasteur 2 - Service d'Ophtalmologie

Nice, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aqueous humor samples collection

Procedure

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.

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: TARMAC-1

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2018
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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