Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration (TARMAC-1)

March 20, 2026 updated by: Centre Hospitalier Universitaire de Nice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06001
        • Hôpital Pasteur 2 - Service d'Ophtalmologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with exudative AMD
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months
Time Frame: At Month 3
At Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose of VEGF in the aqueous humor of patients with exudative AMD
Time Frame: At Day 0, Month 1, Month 2, Month 3
At Day 0, Month 1, Month 2, Month 3
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
At Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with Snellen chart
Time Frame: At Day 0, Month 1, Month 2, Month 3
At Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with ETDRS visual acuity chart
Time Frame: At Day 0, Month 1, Month 2, Month 3
At Day 0, Month 1, Month 2, Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Prof. Stéphanie BAILLIF, MD, PhD, Centre Hospitalier Universitaire De Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

August 19, 2021

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-PP-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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