Comparison of Treatment rOutine Using afLibERcept: Strict vs relAxed retreatmeNT Regimen

• Status: Active, not recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to test non-inferiority of aflibercept "treat and extend" using a relaxed retinal fluid management relative to aflibercept "treat and extend" using a strict retinal fluid management SD-OCT (spectral domain optical coherence tomography) disease activity guided retreatment with respect to best-corrected visual acuity (BCVA) from baseline to end of treatment.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

General:

• Informed consent as documented by signature of the patient on the informed consent form.

• Male or female, ≥50 years of age.

Study eye:

• Diagnosis ofl CNV secondary to wAMD without restriction of lesion size, with visual impairment due to an active wAMD lesion. Active wAMD lesions are characterised by the following:

• Evidence of SRF and/or IRF and

• area of fibrosis less than 50% of the lesion area.

• CNV membrane confirmed by presence of active leakage from the area of CNV seen by fluorescein angiography (FA) and color fundus photography (CFP) and at least two of the following items:

• Drusen

• Retinal Pigment Epithelium (RPE)-Atrophy

• Exudates

• Subretinal or intraretinal haemorrhage

• BCVA scores at both screening and baseline must be 23 letters or more as measured by the ETDRS-like charts (or approximate Snellen equivalent to 20/320).

Exclusion Criteria:

General:

• Inability to comply with study or follow-up procedures.

• Pregnant or nursing (lactating) women.

• Women of child-bearing potential, not using or not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases. (Female participants who are surgically sterilised/hysterectomised, or post-menopausal for longer than 2 years are not considered as being of child-bearing potential.)

• Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.

• Stroke or myocardial infarction less than 3 months prior to the date of informed consent signature.

• Uncontrolled blood pressure defined as systolic value of >160 mmHg or diastolic value of >100 mmHg at screening or baseline.

• Known hypersensitivity to aflibercept or any component of the aflibercept formulation, or fluorescein.

• Prior or current use of any systemic anti-VEGF drugs [e.g., bevacizumab (Avastin®) or ranibizumab (Lucentis®)].

• Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including chloroquine/hydroxychloroquine (Plaquenil®), deferoxamine, phenothiazines, tamoxifen, and ethambutol.

• Use of systemic or intravitreal corticosteroids for at least 30 consecutive days within 3 months prior to the date of informed consent signature.

• Use of other investigational drugs within 6 months prior to the date of informed consent signature.

• Patient was previously screened for participation in the study and was a screen failure.

Both eyes:

• Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of screening or baseline.

• Uncontrolled glaucoma [intraocular pressure (IOP) ≥30 mmHg on medication or according to Investigator's judgment] at the time of screening or baseline.

• Neovascularisation of the iris or neovascular glaucoma at the time of screening or baseline.

• Inability of obtaining SD-OCT images of sufficient quality to be analysed.

• Any intraocular procedure (including Yttrium-Aluminum-Garnet capsulotomy) within 2 months prior to the date of informed consent signature or anticipated within the next 6 months following the date of informed consent signature.

• Intravitreal or topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to the date of informed consent signature.

Study eye:

• Visually significant cataract, aphakia, pseudoexfoliation glaucoma, vitreous haemorrhage, rhegmatogenous retinal detachment, proliferative diabetic retinopathy or CNV of any cause other than wAMD at the time of screening and baseline.

• Structural damage within 0.5 disc diameter of the centre of the macula at the time of screening or baseline that in the Investigator's opinion could preclude visual function improvement with treatment.

• Subretinal hemorrhage involving the central foveal subfield which is 1 or more disc areas in size at the time of screening or baseline.

• Intraocular treatment with any anti-angiogenic drug (including any anti-VEGF agents) prior to the date of informed consent signature.