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

NCT ID: NCT05672979

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brolucizumab treated

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.

Group Type: EXPERIMENTAL

Brolucizumab Injection [Beovu]

Intervention Type: DRUG

brolucizumab 6mg intravitreal injection

Interventions

Brolucizumab Injection [Beovu]

brolucizumab 6mg intravitreal injection

Intervention Type: DRUG

Eligibility Criteria

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)

Exclusion Criteria

1. 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)

2. 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.

3. Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)

4. Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)

5. 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.

6. Stroke or myocardial infarction during the 6-month period prior to baseline

7. 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).

8. Systemic anti-VEGF therapy at any time.

9. 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.

10. 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.

11. Use of other investigational drugs within 5 half-lives of Baseline, or within 30 days /until the expected pharmacodynamic effect has returned to Baseline, whichever is longer; or longer if required by local regulations (observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary).

12. Physically absence of fellow eye (last eye)

13. 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).

14. 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
• Male sterilization (at least 6 months prior to Screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Yeungnam University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Min Sagong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Min Sagong, PhD

Role: CONTACT

msagong@ynu.ac.kr

82536203443

Other Identifiers

YUMC 2022-11-016

Identifier Type: -

Identifier Source: org_study_id