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

Last updated: December 21, 2022
Sponsor: Yeungnam University College of Medicine
Overall Status: Active - Not Recruiting

Phase

3

Condition

Aging

Myopic Macular Degeneration

Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT05672979
YUMC 2022-11-016
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thecentral 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, usingEarly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts atboth 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 theInvestigator deems it more appropriate to select the eye with better visual acuity,based on medical reasons or local ethical requirements.

Exclusion

Exclusion Criteria:

  1. Ocular conditions/disorders at screening or baseline which could, in the opinion ofthe investigator, prevent response to study treatment or may confound interpretationof study results, compromise visual acuity or require planned medical or surgicalintervention 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 choroidalvasculopathy (aneurysmal type-1 neovascularization), myopic choroidalneovascularization, or other ocular disorders requiring anti-VEGF treatment.
  3. Any active intraocular or periocular infection or active intraocular inflammation, atscreening 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 periocularsteroids within the 6-month period prior to baseline, history of any macular lasertreatment or PDT, ocular surgery except cataract surgery within 3 months prior tobaseline 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 pressuremeasurement, it should be repeated after 20 minutes. If the repeat measurement iselevated, 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 todrugs of similar chemical classes, or clinically relevant sensitivity to fluoresceindye as assessed by the Investigator.
  10. History of malignancy of any organ system (other than localized basal cell carcinomaof the skin or in situ cervical cancer), treated or untreated, within the past 5years, 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 islonger; or longer if required by local regulations (observational clinical studiessolely involving over-the-counter vitamins, supplements, or diets are notexclusionary).
  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 visualacuity (VA), e.g. cataract).
  14. Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring the study treatment administration and for one month after stopping theinvestigational medication. Highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle ofthe participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal,post-ovulation methods) and withdrawal are not acceptable methods ofcontraception
  • Female sterilization (have had surgical bilateral oophorectomy with or withouthysterectomy), total hysterectomy, or tubal ligation at least six weeks beforetaking study treatment. In case of oophorectomy alone, only when the reproductivestatus of the woman has been confirmed by follow up hormone level assessment
  • Male sterilization (at least 6 months prior to Screening). For femaleparticipants on the study, the vasectomized male partner should be the solepartner for that participant Use of oral (estrogen and progesterone), injected orimplanted hormonal methods of contraception or placement of an intrauterinedevice (IUD) or intrauterine system (IUS), or other forms of hormonalcontraception that have comparable efficacy (failure rate <1%), for examplehormone vaginal ring or transdermal hormone contraception.

Study Design

Total Participants: 36
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2024