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

NCT03630562 | Completed DMC

• 1 other identifier: 17-PP-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

  At Month 3

Secondary Outcomes (4)

• Dose of VEGF in the aqueous humor of patients with exudative AMD

  At Day 0, Month 1, Month 2, Month 3

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

  At Day 0, Month 1, Month 2, Month 3

• Measurement of visual acuity with Snellen chart

  At Day 0, Month 1, Month 2, Month 3

• Measurement of visual acuity with ETDRS visual acuity chart

  At Day 0, Month 1, Month 2, Month 3

Study Arms (1)

Patients with exudative AMD

OTHER

Procedure: Aqueous humor samples collection

Interventions

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.

Patients with exudative AMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital Pasteur 2 - Service d'Ophtalmologie

Nice, 06001, France

Location

Related Publications (1)

• 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.

  PMID: 31445509 RESULT

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Prof. Stéphanie BAILLIF, MD, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: August 15, 2018
• Study Start: November 26, 2018
• Primary Completion: January 12, 2021
• Study Completion: August 19, 2021
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)