Age-Related Macular Degeneration, Pachychoroid Neovasculopathy
Conditions
Brief summary
PNV is a recently described clinical entity; therefore, studies about treatment efficacy and safety are few, with limited follow-up and a small number of participants. Treatment is based on intravitreal anti-VEGF injections, similar to neovascular AMD. According to reported results however, efficacy seems different in fluid reabsorption among anti-VEGF agents. A newly developed anti-VEGF molecule for the treatment of neovascular AMD, brolucizumab, has been shown in clinical studies to have longer durability and improved visual outcomes using a q12-week regimen, thus having the potential to reduce treatment burden and serve as an important therapeutic tool in the management of neovascular AMD. Nevertheless, there have been no reports specifically focusing on the efficacy of brolucizumab in the treatment of PNV. The purpose of this study is to evaluate the efficacy and safety profile of the modified treat-and-extend regimen to 64 weeks by intravitreal brolucizumab injection in eyes with treatment-naive pachychoroid neovasculopathy (PNV) patients.
Interventions
DRUGBrolucizumab Injection [Beovu]
brolucizumab 6mg intravitreal injection
Sponsors
Novartis
Yeungnam University College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female patients ≥ 19 years of age at screening 3. Treatment-na¨ıve pachychoroid neovasculopathy (Minimum cutoff value of SFCT 300 μm) 4. Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye) 5. Best-corrected visual acuity (BCVA) score between 83 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye) 6. If both eyes are eligible as per the inclusion and
Exclusion criteria
described below, the eye with the worse visual acuity should be selected for study eye, unless the Investigator deems it more appropriate to select the eye with better visual acuity, based on medical reasons or local ethical requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in best corrected visual acuity | Week 32 | Mean change from baseline in best corrected visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of the last interval | up to Week 32 and Week 64 | Distribution of the last interval with no disease activity |
| Distribution of the maximal interval | Week 64 | Distribution of the maximal intervals with no disease activity |
| Time from the last loading injection to the first visit with no disease activity | Week 64 | Time from the last loading injection to the first visit with no disease activity |
| Proportion of patients with no disease activity | Week 12 | Proportion of patients with no disease activity |
| Proportion of patients with complete fluid absorption | Week 12, Week 16 | Proportion of patients with complete fluid absorption |
Contacts
Primary ContactMin Sagong, PhD
Outcome results
None listed