Comparison of brolucizumab and aflibercept in retinal angiomatous proliferation form of wet age related macular degeneration - prospective randomised study
- Conditions
- Retinal angiomatous proliferation form of neovascular age related macular degeneration (AMD).Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2021-001058-73-CZ
- Lead Sponsor
- Fakultní nemocnice Královské Vinohrady
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1. age of 50 years or more at the time the informed consent is signed
2. active RAP in the macula including fovea diagnosed on OCT and OCT angiography (OCTa)
3. BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen
equivalent) in the study eye
4. decrease in BCVA caused primarily by the RAP in the study eye
5. presence of intra- or subretinal fluid or PED in the central 1 mm of the
macula on the OCT
6. patient capable of signing the informed consent
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1. other causes of choroidal neovascular membrane (CNV) than wAMD
2. previous or current conditions of the study eye:
a. subretinal haemorrhage comprising more than 25% of the lesion in the study eye
b. scar or fibrosis comprising more than 50% of the lesion in the study eye
c. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
d. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
e. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
f. idiopathic or autoimmune uveitis in the study eye
g. other pathologies in the macula of the study eye which can be expected to influence the BCVA (e.g. macular hole, retinal atrophy, epiretinal membrane, etc.)
h. history of glaucoma surgery in the study eye or probability that it will be necessary in the future
i. aphakia or pseudophakia with absence of the posterior lens capsule (with the exception of missing posterior capsule due to Nd:YAG laser capsulotomy) in the study eye
j. myopia in the study eye with spherical equivalent of more than 8 dioptries before any refractive or cataract surgery
k. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or FP or OCT examination
l. corneal transplantation or corneal dystrophy in the study eye
m. irregular astigmatism or BCVA-lowering amblyopia in the study eye
n. diabetic retinopathy, diabetic macular edema or any other retinal
vascular disease in the study eye
o. extraocular or periocular infection or inflammation (e.g. blepharitis,
keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of
screening or baseline visit
p. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
q. previous treatment with intravitreal or periocular antiVEGF or corticosteroids in the study eye
r. treatment with systemic intravenous antiVEGF or corticosteroids during 12 weeks (84 days) before the screening visit
3. allergy or hypersensitivity to any component contained in the study
drug
4. pregnant or breastfeeding women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the change in best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT<br>and number of injections in patients with retinal angiomatous proliferation (RAP) treated with brolucizumab and aflibercept.;Secondary Objective: To compare the number of patients without any intra- or subretinal fluid and PED on the OCT, number of patients who gained more than 15 ETDRS letters in each group, number of patients who lost more than 15 ETDRS letters in each group, number of drug or procedure related adverse events, such as uveitis, retinal breaks, intraocular haemorrhage etc. and number of patients who received rescue therapy in each group.;Primary end point(s): 1. Best corrected visual acuity (BCVA)<br>BCVA change from baseline to week 52 in ETDRS letters.<br>2. Central retinal thickness (CRT)<br>CRT change on OCT from baseline to week 52.<br>3. Number of injections<br>Average number of injections per patient in each group.;Timepoint(s) of evaluation of this end point: Week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 4. Dry macula<br>Number of patients without any intra- or subretinal fluid and pigment epithelium detachment (PED) on the OCT examination at week 52.<br>5. Significant visual gain<br>Number of patients who gained more than 15 ETDRS letters in each group.<br>6. Significant visual loss<br>Number of patients who lost more than 15 ETDRS letters in each group.<br>7. Adverse events<br>Number of drug or procedure related adverse events, such as uveitis, retinal breaks, intraocular haemorrhage etc.<br>8. Rescue<br>Number of patients who received rescue therapy in each group.;Timepoint(s) of evaluation of this end point: Week 52