Investigation of effectiveness of intravitreal aflibercept treatment in special forms of exsudative maculopathies

Phase 1

• Conditions: Exsudative Maculopathies; MedDRA version: 17.0Level: PTClassification code 10063381Term: Polypoidal choroidal vasculopathySystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10052501Term: Detachment of retinal pigment epitheliumSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: LLTClassification code 10069125Term: Retinal angiomatous proliferationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10060823Term: Choroidal neovascularisationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-002384-15-AT
• Lead Sponsor: niversitätsklinik für Augenheilkunde und Optometrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-19
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Treatment naïve eyes with following subtypes of exsudative maculopathies will be included:
•Retinal angiomatous proliferation lesions (RAP)
•Pigment epithelium detachment (PED)
•Hemorrhagic CNV (if the size of hemorrhage is either >50% of the lesion area or >1 disk area in size) )
•Polypoidal choroidal vasculopathy (PCV)
Patients who have a BCVA score better than 20/400 in the study eye using ETDRS
Willingness and able to comply with clinic visits and study-related procedures
Proved a signed informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Any prior treatment for exsudative maculopathy including photodynamic therapy and intravitreal anti-VEGF application in the study eye
Any surgical treatment of the eye within 3 months prior to baseline in the study eye
History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.)
History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma mediation)
Aphakia or absence of the posterior capsule in the study eye
Presence of a retinal pigment epithelial tear involving the macula in the study eye.
Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the twelve-month study period to prevent or treat visual loss that might result from that condition
Active intraocular inflammation (grade trace or above) in the study eye.
Active or suspected ocular or periocular infection in the study eye.
Any active infection involving eyeball adnexa
Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
in the study eye
Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
Other ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within six months prior to screening or during the course of the study.
Pregnant or breast-feeding women.
Women of childbearing potential with either a positive pregnancy test result or no
pregnancy test at baseline are excluded. Postmenopausal women must be amenorrheic
for at least 12 months in order not to be considered of child bearing potential.
Sexually active men or women of childbearing potential who are unwilling to practice
adequate contraception during the study are excluded. (adequate contraceptive
measures include stable use of oral contraceptives or other prescription
pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening;
intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus
contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or
jelly)
Allergy to fluorescein
Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified