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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aqueous humor samples collection
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age Related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Pasteur 2 - Service d'Ophtalmologie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with exudative AMD

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dose of VEGF in the aqueous humor of patients with exudative AMD
Dose of pro inflammatory cytokines in the aqueous humor of patients with exudative AMD
Measurement of visual acuity with Snellen chart
Measurement of visual acuity with ETDRS visual acuity chart

Full Information

First Posted
January 12, 2018
Last Updated
April 11, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT03630562
Brief Title
Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration
Acronym
TARMAC-1
Official Title
Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
August 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with exudative AMD
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Aqueous humor samples collection
Intervention Description
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 Outcome Measure Information:
Title
Change of pro-angiogenic cytokines concentration in the aqueous humor of patients with exudative AMD at 3 months
Time Frame
At Month 3
Secondary Outcome Measure Information:
Title
Dose of VEGF in the aqueous humor of patients with exudative AMD
Time Frame
At Day 0, Month 1, Month 2, Month 3
Title
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
Title
Measurement of visual acuity with Snellen chart
Time Frame
At Day 0, Month 1, Month 2, Month 3
Title
Measurement of visual acuity with ETDRS visual acuity chart
Time Frame
At Day 0, Month 1, Month 2, Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Stéphanie BAILLIF, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pasteur 2 - Service d'Ophtalmologie
City
Nice
ZIP/Postal Code
06001
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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