Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02157077
Other study ID # ARI2
Secondary ID 2013-002869-19
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2013
Est. completion date December 2015

Study information

Verified date December 2022
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis. The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.


Description:

The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Men and women = 50 years of age - Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affect the fovea evidenced by Fluorescein Angiography in the study eye - Patient having been treated for at least 12 months with Ranibizumab (= 8 injections) - Patient with a PED > 250 µm, defined by spectral domain optical coherent tomography (SD-OCT), measured at two consecutive visits before inclusion with any persisting sub retinal fluid at baseline - Patient affiliated to a social security scheme - Signed Informed Consent Exclusion Criteria: - Patient with subfoveal atrophy and/or atrophy with a diameter greater than 150µm in the subfoveal or juxtafoveal area - Patient with a subfoveal fibrosis - Subretinal hemorrhage that is either 50 percent or more of the total lesion area or 1 or more disc areas in size in the study eye. - Scar, fibrosis or atrophy making up > 50% of total lesion in the study eye. - Presence of retinal pigment epithelial tears or rips involving the macula in the study eye. - History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye. - Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye. - Any history of macular hole of stage 3 and above in the study eye. - Uncontrolled glaucoma (defined as intraocular pressure =25 mmHg despite treatment with antiglaucoma medication) or prior laser treatment for glaucoma in the study eye. - Active intraocular inflammation or uveitis of scleritis or episcleritis in the study eye or ocular or periocular infection in either eye - Presence or history of scleromalacia in the study eye. - Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye. - Previous therapeutic radiation in the study eye. - History of corneal transplant or corneal dystrophy in the study eye. - Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of toxicity, or fundus photography. - Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 24 month study period. - Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety. - Any systemic treatment with an investigational agent except dietary supplements or vitamins in the past 6 months prior to Day 1 for any condition. - Any history of allergy to povidone iodine. - Contraindications as listed - Patient enrolled in another interventional research or not - Patient already included in the study for the treatment of one of his eye - Pregnant or nursing woman - Lack of effective contraception for women of childbearing age

Study Design


Intervention

Drug:
Aflibercept
Intravitreal Injection

Locations

Country Name City State
France Hôpital Pellegrin Bordeaux
France Centre Hospitalier Intercommunal de Créteil Créteil
France Hôpital général de Dijon Dijon
France Centre d'Ophtalmologie Rabelais Lyon
France Cabinet Alpes Rétine Montbonnot-Saint-Martin
France CHR Hôtel Dieu Nantes
France Centre d'explorations ophtalmologiques de l'odéon Paris
France Hôpital des Quinze-Vingts Paris
France Clinique Mathilde Rouen

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil Bayer

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks Baseline and 12 weeks
Secondary Change from baseline in central retinal thickness by SD OCT at 12 weeks Baseline and 12 weeks
Secondary Change from Baseline in visual acuity at 12 weeks Baseline and 12 weeks
Secondary Change from Baseline in volume of pigment epithelium detachment at 12 weeks Baseline and 12 weeks
Secondary Association with genes involved in AMD history genetic testing will be performed when all the particpitants will be recruited
Secondary Number of participants with adverse events from baseline to 32 weeks from baseline to 32 weeks
Secondary Change from Baseline in pigment epithelium detachment height at 12 weeks Baseline and 12 weeks
Secondary Change from baseline in central retinal thickness at 32 weeks baseline and 32 weeks
Secondary Change from Baseline in pigment epithelium detachment height at 32 weeks Baseline and 32 weeks
Secondary Change from Baseline in visual acuity at 32 weeks Baseline and 32 weeks
Secondary Change from Baseline in volume of pigment epithelium detachment at 32 weeks Baseline and 32 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Completed NCT02540954 - Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD) Phase 3
Completed NCT00385333 - Metabolic Mapping to Measure Retinal Metabolism Phase 2
Completed NCT02510794 - Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration Phase 2
Completed NCT02181504 - A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration Phase 2
Terminated NCT02228304 - Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT01204541 - A Single-Center Pilot Study to Assess Macular Function N/A
Completed NCT00769392 - Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection N/A
Completed NCT00536016 - A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD Phase 1
Completed NCT00533520 - Evaluation of Dosing Interval of Higher Doses of Ranibizumab Phase 4
Withdrawn NCT00538538 - Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD) Phase 1
Terminated NCT00403442 - Bevacizumab in Combination With Verteporfin Reduced and Standard Fluence in the Treatment of Hemorrhaged Lesions in Neovascular AMD Phase 1
Recruiting NCT00157976 - Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration Phase 3
Completed NCT00242580 - A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib Phase 3
Completed NCT00239928 - Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration Phase 2
Completed NCT00211458 - Treatment of Age-Related Macular Degeneration With Anecortave Acetate Phase 2
Completed NCT00095433 - Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD) Phase 3
Completed NCT00006202 - Lutein for Age-Related Macular Degeneration Phase 2