Age Related Macular DegenerationTARMAC-1NCT03630562
Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration
A study testing Aqueous humor samples collection in people with Age Related Macular Degeneration, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Aqueous humor samples collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2018to 19 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Aqueous humor samples collection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous humor samples collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with exudative AMD | Other | Not described Receives: Procedure: Aqueous humor samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months
Measured: At Month 3
Secondary outcomes (4)
Dose of VEGF in the aqueous humor of patients with exudative AMD
Measured: At Day 0, Month 1, Month 2, Month 3
Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMD
Measured: At Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with Snellen chart
Measured: At Day 0, Month 1, Month 2, Month 3
Measurement of visual acuity with ETDRS visual acuity chart
Measured: At Day 0, Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start26 Nov 2018
- Primary completion12 Jan 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Stéphanie BAILLIF, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630562
- Sponsor's protocol ID
- 17-PP-18
- Acronym
- TARMAC-1
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2018
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 31445509Baillif 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03630562
- Acronym / sponsor ID
- TARMAC-1 / 17-PP-18
- Conditions
- Age Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with exudative AMD | Other | Procedure: Aqueous humor samples collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqueous humor samples collectionIn 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. | Procedure or surgery | Patients with exudative AMD |
Primary outcome
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months
Time frame: At Month 3
4 secondary outcomes
Dose of VEGF in the aqueous humor of patients with exudative AMD
Time frame: 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
Measurement of visual acuity with Snellen chart
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 31445509Lopez-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.
- Derived from this study: PubMed 40147376Baillif 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Stéphanie BAILLIF, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqueous humor samples collection in people with Age Related Macular Degeneration, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months (time frame: At Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03630562, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.