Prospective triAl of Modified Treat-and-extend Regimens With BroLucizumab in pachychOroid Neovasculopathy

NCT05672979 | Unknown Phase 3

• 1 other identifier: YUMC 2022-11-016
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Age-Related Macular Degeneration; Pachychoroid Neovasculopathy

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in best corrected visual acuity

  Mean change from baseline in best corrected visual acuity

  Week 32

Secondary Outcomes (5)

• Distribution of the last interval

  up to Week 32 and Week 64

• Distribution of the maximal interval

  Week 64

• Time from the last loading injection to the first visit with no disease activity

  Week 64

• Proportion of patients with no disease activity

  Week 12

• Proportion of patients with complete fluid absorption

  Week 12, Week 16

Study Arms (1)

Brolucizumab treated

EXPERIMENTAL

Intravitreal brolucizumab 6mg injection. Initial treatment consists of a loading dose of three intravitreal injections of brolucizumab at monthly intervals. After 3 loading doses, patients are followed by monthly observation visits until the month 6 and bimonthly afterwards until disease-recurrence interval is determined (It can be monthly as per the investigator's judgement.). Following loading phase, the first treatment interval is determined by patients' disease recurrent interval, 1 month shorter than first recurrence interval (maximum first injection interval is 16 weeks). The injection interval is shortened if there is any fluid change or decreased visual acuity. If the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit, the injection interval is maintained. And the interval is extended if there was no fluid on OCT. The minimum and maximum injection intervals are 8 and 16 weeks, respectively.

Drug: Brolucizumab Injection [Beovu]

Interventions

Brolucizumab Injection [Beovu] DRUG

brolucizumab 6mg intravitreal injection

Brolucizumab treated

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• Male or female patients ≥ 19 years of age at screening
• Treatment-na¨ıve pachychoroid neovasculopathy (Minimum cutoff value of SFCT 300 μm)
• 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)
• 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)

You may not qualify if:

• Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
• A history of any evidence of type 2 or type 3 neovascularization, polypoidal choroidal vasculopathy (aneurysmal type-1 neovascularization), myopic choroidal neovascularization, or other ocular disorders requiring anti-VEGF treatment.
• Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
• Uncontrolled glaucoma defined as intraocular pressure (IOP) \> 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)
• Ocular treatments: previous treatment with any anti-vascular endothelial growth factor (VEGF) drugs or investigational drugs, previous use of intraocular or periocular steroids within the 6-month period prior to baseline, history of any macular laser treatment or PDT, ocular surgery except cataract surgery within 3 months prior to baseline will be excluded.
• Stroke or myocardial infarction during the 6-month period prior to baseline
• Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg at Screening or Baseline. (In case there is an elevated blood pressure measurement, it should be repeated after 20 minutes. If the repeat measurement is elevated, then the participant is not eligible to be enrolled into the study).
• Systemic anti-VEGF therapy at any time.
• History of hypersensitivity to any of the study treatment or its excipients or to drugs of similar chemical classes, or clinically relevant sensitivity to fluorescein dye as assessed by the Investigator.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Physically absence of fellow eye (last eye)
• Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \<20/200 at Screening (except when due to conditions whose surgery may improve visual acuity (VA), e.g. cataract).
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment administration and for one month after stopping the investigational medication. Highly effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead
• Novartis: collaborator

MeSH Terms

Conditions

Macular Degeneration

Interventions

brolucizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Min Sagong, PhD

CONTACT

82536203443; msagong@ynu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 5, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 5, 2023

Record last verified: 2022-12