Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration

NCT02157077 | Completed Phase 3 DMC

• 2 other identifiers: ARI22013-002869-19
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Keywords

Eye diseases; Vision Impairment and Blindness; Eyes and Vision; Seniors; Neovascular Age-Related Macular Degeneration (AMD); Retinal Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks

  Baseline and 12 weeks

Secondary Outcomes (10)

• Change from baseline in central retinal thickness by SD OCT at 12 weeks

  Baseline and 12 weeks

• Change from Baseline in visual acuity at 12 weeks

  Baseline and 12 weeks

• Change from Baseline in volume of pigment epithelium detachment at 12 weeks

  Baseline and 12 weeks

• Association with genes involved in AMD history

  genetic testing will be performed when all the particpitants will be recruited

• Number of participants with adverse events from baseline to 32 weeks

  from baseline to 32 weeks

Study Arms (1)

Aflibercept

EXPERIMENTAL

Patients will receive 2 mg of aflibercept by intravitreal injection every 4 weeks until week 8, followed by every 6 weeks to week 26

Drug: Aflibercept

Interventions

Aflibercept DRUG

Intravitreal Injection

Also known as: Eylea, BAY86-5321

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 affiliated to a social security scheme
• Signed Informed Consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Bayer: collaborator

Study Sites (9)

Hôpital Pellegrin

Bordeaux, 33000, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

Hôpital général de Dijon

Dijon, 21033, France

Location

Centre d'Ophtalmologie Rabelais

Lyon, 69003, France

Location

Cabinet Alpes Rétine

Montbonnot-Saint-Martin, 38330, France

Location

CHR Hôtel Dieu

Nantes, 44093, France

Location

Centre d'explorations ophtalmologiques de l'odéon

Paris, 75006, France

Location

Hôpital des Quinze-Vingts

Paris, 75012, France

Location

Clinique Mathilde

Rouen, 76100, France

Location

Related Publications (1)

• Mouallem-Beziere A, Blanco-Garavito R, Richard F, Miere A, Jung C, Rozet JM, Souied EH. GENETICS OF LARGE PIGMENT EPITHELIAL DETACHMENTS IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Apr;40(4):663-671. doi: 10.1097/IAE.0000000000002454.

  PMID: 30681643 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders; Blindness

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Souied, MD

  Centre Hospitalier Intersommunal de Créteil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2014
• First Posted: June 5, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

FR (9)