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Age-Related Macular DegenerationPhase 3PABLONCT05672979

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

A Phase 3 study testing Brolucizumab Injection [Beovu] in people with Age-Related Macular Degeneration and Pachychoroid Neovasculopathy, run by Yeungnam University College of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
Brolucizumab Injection [Beovu]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 Jan 2023to 31 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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.
  • 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).
  • 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
  • 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.

Trial locations and contacts

No sites are listed yet.

Min Sagong, PhD contact

82536203443

msagong@ynu.ac.kr

About this study

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.

Being tested
Brolucizumab Injection [Beovu]
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brolucizumab Injection [Beovu]Drug

    brolucizumab 6mg intravitreal injection

Study groups in NCT05672979
Study groupRoleWhat they receive
Brolucizumab treatedExperimentalIntravitreal 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.
Receives: Drug: Brolucizumab Injection [Beovu]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in best corrected visual acuity

    Mean change from baseline in best corrected visual acuity

    Measured: Week 32

Secondary outcomes (5)

  1. Distribution of the last interval

    Distribution of the last interval with no disease activity

    Measured: up to Week 32 and Week 64

  2. Distribution of the maximal interval

    Distribution of the maximal intervals with no disease activity

    Measured: Week 64

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

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

    Measured: Week 64

  4. Proportion of patients with no disease activity

    Proportion of patients with no disease activity

    Measured: Week 12

  5. Proportion of patients with complete fluid absorption

    Proportion of patients with complete fluid absorption

    Measured: Week 12, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672979
Sponsor's protocol ID
YUMC 2022-11-016
Acronym
PABLO
Status last verified
Dec 2022
First submitted
21 Dec 2022
Last updated
5 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brolucizumab Injection [Beovu] in people with Age-Related Macular Degeneration and Pachychoroid Neovasculopathy, run by Yeungnam University College of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Min Sagong, PhD (82536203443, msagong@ynu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in best corrected visual acuity (time frame: Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.

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