Polypoidal Choroidal VasculopathyNCT04707027
Interval of Disease Inactivity After Complete Polypoidal Regression in PCV Receiving Aflibercept
A study testing Aflibercept Injection (2 mg/0.05 ml) and Defer treatment in people with Polypoidal Choroidal Vasculopathy, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Polypoidal choroidal vasculopathy (PCV), a subtype of neovascular age-related macular degeneration (NV AMD), is an important cause of central visual loss, especially among Asian and African descendants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- Aflibercept Injection (2 mg/0.05 ml) and Defer treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2020to Nov 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of ≥18 years
- Diagnosis of treatment-naïve PCV in either eye
- PCV is defined according to the following criteria Presence of focal subretinal ICGA hyperfluorescence within the first 6 minutes, plus one of the followings; 1) subretinal orange nodule corresponds to hyperfluorescent nodule on ICGA, 2) massive submacular hemorrhage of 4 disc area or larger, 3) nodular appearance on stereoscopic viewing, 4) pulsatile polypoidal lesion, 5) abnormal vascular channel supplying the polypoidal lesion, 6) hypofluorescent halo around the nodule6
- If any participant presents with bilateral PCV in which both eyes are eligible for the study, the eye with worse vision will be chosen as the study eye
Who cannot join
- Presence of co-existing vision threatening conditions in the study eye, e.g., diabetic retinopathy, or retinal vascular occlusion
- Presence of ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in aflibercept
- Inability to obtain good quality imaging due to ocular media abnormalities
- Contraindicate for FFA or ICGA due to the following conditions:
- Allergic to fluorescein or indocyanine green dye
- Allergic to iodine or seafood
- Impaired kidney or liver functions
- Not able to follow up according to the study protocol
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Voraporn Chaikitmongkol
Chiang Mai, 50200
Voraporn Chaikitmongkol, MD, 66-53-935512, vchaikitmongkol@gmail.com
Apisara Sangkaew, sangkaew.as@gmail.com
About this study
Official title: Interval of Disease Inactivity After Complete Polypoidal Regression on ICGA in Eyes With Polypoidal Choroidal Vasculopathy Following Intravitreous Aflibercept Treatment
Polypoidal choroidal vasculopathy (PCV), a subtype of neovascular age-related macular degeneration (NV AMD), is an important cause of central visual loss, especially among Asian and African descendants. PCV is characterized by the presence of hyperfluorescent polypoidal lesions, with or without branching vascular network, identified on indocyanine green angiography (ICGA), currently the gold standard for PCV diagnosis.
In addition to visual improvement from baseline, polypoidal regression or complete disappearance of polypoidal lesions on ICGA has been considered an important treatment outcome in large PCV trials including the PLANET1 and EVEREST II2 studies. Rate of polypoidal regression following intravitreous aflibercept monotherapy was 33% in the PLANET study1 year 2 and ranged between 55% to 78% in other Asian cohorts.3-4
Read more
Recently, our previous investigation5 on the timing of polypoidal regression following a fixed-dosing aflibercept monotherapy (3 initial monthly injections, then q 8 weeks until 1 year) in 40 Thai PCV eyes suggested that, among 22 eyes (55%) with polypoidal regression at 1 year, a majority of them showed complete polypoidal regression before 6 months (median duration of complete regression: 3 months (IQR, 2 months to 6 months).
However, due to the fixed-dosing regimen used in previous study, there are limited data on how often polypoidal lesions remain regressed on ICGA when the treatment is deferred in eyes with polypoidal regression, nor what changes might be seen subsequently on OCT when treatment is deferred in this situation. Therefore, this study aims to determine the changes seen on OCT subsequent to complete regression of polypoidal lesions on ICGA in PCV eyes following intravitreous aflibercept treatment.
Results from this study may provide some insights on longer-term PCV management
Read the detailed description
Primary objective:
To determine how long there is CNV inactivity on OCT (absence of intraretinal thickening, intraretinal cystoid abnormalities, subretinal fluid, or enlarging pigment epithelial detachments) in eyes with complete polypoidal regression on ICGA after receiving intravitreous aflibercept injections over 2 years for PCV
Secondary objectives:
- To determine the rate of polypoidal regression compared with baseline at 3, 6, 12, and 24 months following intravitreous aflibercept "treat and extend" regimen
- To determine the visual acuity change from baseline to 1 and 2 years following intravitreous aflibercept "modified treat and extend" regimen and its correlation with OCT or ICGA activity.
- To determine the correlation of changes at week 12 with changes at 12 months and 24 months
- To determine the incidence of newly developed or recurrent polypoidal lesions in eyes with complete polypoidal regression after aflibercept treatment "treat and extend" regimen over 2 years
Study design:
Multi-center prospective case series. The overall study duration will be 3 years; 1 year for recruitment and 2-year follow-up for each participant
Methods
- Overall study duration for each participant will be 24 months
- Eligible participants will receive 3 initial monthly intravitreous 2-mg aflibercept injections (week 0, 4, 8), then management will be based on ICGA findings at week 12 as follows:
- Complete polypoidal regression on ICGA: defer intravitreous aflibercept injection, and follow-up monthly with OCT monitoring thereafter until 1 year, and bimonthly in year 2. If subretinal or intraretinal fluid is seen on OCT during the follow-up period, an interval of disease inactivity is determined. Such study eye with re-activation is considered met primary end point and will receive intravitreous anti-VEGF treatment according to "treat and extend" regimen as described below.
- Incomplete or worsening polypoidal regression on ICGA: continue additional 3 intravitreous aflibercept injection, and repeat ICGA at week 24
- At week 24, if there is a presence of complete polypoidal regression on ICGA, defer intravitreous aflibercept injection, and follow-up monthly with OCT monitoring thereafter until 1 year, and bimonthly in year 2. If subretinal or intraretinal fluid is seen on OCT during the follow-up period, an interval of disease inactivity (primary outcome) is determined. Such study eye with re-activation is considered met primary end point and will receive intravitreous anti-VEGF treatment according to "treat and extend" regimen as described below.
- At week 24, if there is partial or no regression of polypoidal lesion, continue intravitreous aflibercept injection with "treat and extend" regimen, which the follow-up interval can be extended by 4 weeks up to 16 weeks if no disease activity identified on color fundus photography or OCT. If disease activity recurs, shorten follow-up interval by 4 weeks, remain injections at that interval until fluid resolved, and re-extend by 2 weeks. Treatment interval will not be less frequent than every 4 weeks (according to an approved label of intravitreous aflibercept in Thailand). During follow-up, if an investigator suspect the presence of complete polypoidal regression based on OCT findings, ICGA can be performed at any visit. If complete polypoidal regression is present, defer the treatment and follow-up monthly with OCT monitoring in year 1, and bimonthly in year 2.
- Photodynamic therapy can be applied at 1 year, if persistent fluid on OCT is identified despite continuous intravitreous aflibercept injections.
Investigations at each visit
- Visual acuity measurement, color fundus photography (CFP), and SD-OCT will be performed at each visit
- Fundus fluorescein angiography (FA) and indocyanine green angiography (ICGA) will be performed at week 0 (baseline), 3, 6, 12, and 24 months, and at any time point showing a recurrence of disease activity in eye that previously shown complete polypoidal regression on ICGA, or at any time point an investigator suspect the presence of complete polypoidal regression based on OCT findings.
Definitions:
- Disease activity on color fundus photography is defined as a presence of new retinal or subretinal or sub-RPE hemorrhage
- Disease activity on OCT is defined as a presence of intraretinal or subretinal fluid or new pigment epithelial detachment
- Polypoidal regression is defined as complete absence of hyperfluorescent lesions in an area that previously had a polypoidal lesion on ICGA at baseline
- Partial polypoidal regression is defined as decrease of hyperfluorescent polypoidal lesions either in size or number or both in an area previously identified as a polypoidal lesion on ICGA at baseline
- Persistent or worsening polypoidal regression is defined as a persistent or enlargement in size and number of hyperfluorescent lesions in an area previously identified as a polypoidal lesion on ICGA at baseline
- Newly developed polypoidal lesion is defined as a presence of a polypoidal lesion not previously identified on ICGA at baseline
- Recurrent polypoidal lesion is defined as a polypoidal lesion in an area previously identified as polypoidal regression on ICGA.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- Aflibercept Injection (2 mg/0.05 ml), Defer treatment
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Injection (2 mg/0.05 ml)Drug
Also called Eylea
Intravitreal aflibercept injections (treat and extend regimen)
Defer treatmentOther
Follow up with fundus photo and OCT every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| complete polypoidal regression arm | Sham comparator | follow up monthly with color fundus photography and OCT at each visit Receives: Other: Defer treatment |
| incomplete polypoidal regression arm | Active comparator | continue treatment with aflibercept injection (treat and extend regimen) Receives: Drug: Aflibercept Injection (2 mg/0.05 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval of disease activity on color fundus photography or optical coherence tomography
- Disease inactivity on color fundus photography is defined as an absence of new retinal or subretinal or sub-RPE hemorrhage on color fundus photography compared with baseline
- Disease inactivity on OCT is defined as an absence of intraretinal thickening or CME or subretinal fluid or PED or enlarging PED on OCT
Measured: 1 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Nov 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal VasculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Voraporn Chaikitmongkol, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707027
- Sponsor's protocol ID
- OPT-2563-07160
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interval of Disease Inactivity After Complete Polypoidal Regression on ICGA in Eyes With Polypoidal Choroidal Vasculopathy Following Intravitreous Aflibercept Treatment
- ClinicalTrials.gov ID
- NCT04707027
- Acronym / sponsor ID
- OPT-2563-07160
- Conditions
- Polypoidal Choroidal Vasculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polypoidal choroidal vasculopathy (PCV), a subtype of neovascular age-related macular degeneration (NV AMD), is an important cause of central visual loss, especially among Asian and African descendants. PCV is characterized by the presence of hyperfluorescent polypoidal lesions, with or without branching vascular network, identified on indocyanine green angiography (ICGA), currently the gold standard for PCV diagnosis.
In addition to visual improvement from baseline, polypoidal regression or complete disappearance of polypoidal lesions on ICGA has been considered an important treatment outcome in large PCV trials including the PLANET1 and EVEREST II2 studies. Rate of polypoidal regression following intravitreous aflibercept monotherapy was 33% in the PLANET study1 year 2 and ranged between 55% to 78% in other Asian cohorts.3-4
Recently, our previous investigation5 on the timing of polypoidal regression following a fixed-dosing aflibercept monotherapy (3 initial monthly injections, then q 8 weeks until 1 year) in 40 Thai PCV eyes suggested that, among 22 eyes (55%) with polypoidal regression at 1 year, a majority of them showed complete polypoidal regression before 6 months (median duration of complete regression: 3 months (IQR, 2 months to 6 months).
However, due to the fixed-dosing regimen used in previous study, there are limited data on how often polypoidal lesions remain regressed on ICGA when the treatment is deferred in eyes with polypoidal regression, nor what changes might be seen subsequently on OCT when treatment is deferred in this situation. Therefore, this study aims to determine the changes seen on OCT subsequent to complete regression of polypoidal lesions on ICGA in PCV eyes following intravitreous aflibercept treatment.
Results from this study may provide some insights on longer-term PCV management
Detailed description
Primary objective:
To determine how long there is CNV inactivity on OCT (absence of intraretinal thickening, intraretinal cystoid abnormalities, subretinal fluid, or enlarging pigment epithelial detachments) in eyes with complete polypoidal regression on ICGA after receiving intravitreous aflibercept injections over 2 years for PCV
Secondary objectives:
- To determine the rate of polypoidal regression compared with baseline at 3, 6, 12, and 24 months following intravitreous aflibercept "treat and extend" regimen
- To determine the visual acuity change from baseline to 1 and 2 years following intravitreous aflibercept "modified treat and extend" regimen and its correlation with OCT or ICGA activity.
- To determine the correlation of changes at week 12 with changes at 12 months and 24 months
- To determine the incidence of newly developed or recurrent polypoidal lesions in eyes with complete polypoidal regression after aflibercept treatment "treat and extend" regimen over 2 years
Study design:
Multi-center prospective case series. The overall study duration will be 3 years; 1 year for recruitment and 2-year follow-up for each participant
Methods
- Overall study duration for each participant will be 24 months
- Eligible participants will receive 3 initial monthly intravitreous 2-mg aflibercept injections (week 0, 4, 8), then management will be based on ICGA findings at week 12 as follows:
- Complete polypoidal regression on ICGA: defer intravitreous aflibercept injection, and follow-up monthly with OCT monitoring thereafter until 1 year, and bimonthly in year 2. If subretinal or intraretinal fluid is seen on OCT during the follow-up period, an interval of disease inactivity is determined. Such study eye with re-activation is considered met primary end point and will receive intravitreous anti-VEGF treatment according to "treat and extend" regimen as described below.
- Incomplete or worsening polypoidal regression on ICGA: continue additional 3 intravitreous aflibercept injection, and repeat ICGA at week 24
- At week 24, if there is a presence of complete polypoidal regression on ICGA, defer intravitreous aflibercept injection, and follow-up monthly with OCT monitoring thereafter until 1 year, and bimonthly in year 2. If subretinal or intraretinal fluid is seen on OCT during the follow-up period, an interval of disease inactivity (primary outcome) is determined. Such study eye with re-activation is considered met primary end point and will receive intravitreous anti-VEGF treatment according to "treat and extend" regimen as described below.
- At week 24, if there is partial or no regression of polypoidal lesion, continue intravitreous aflibercept injection with "treat and extend" regimen, which the follow-up interval can be extended by 4 weeks up to 16 weeks if no disease activity identified on color fundus photography or OCT. If disease activity recurs, shorten follow-up interval by 4 weeks, remain injections at that interval until fluid resolved, and re-extend by 2 weeks. Treatment interval will not be less frequent than every 4 weeks (according to an approved label of intravitreous aflibercept in Thailand). During follow-up, if an investigator suspect the presence of complete polypoidal regression based on OCT findings, ICGA can be performed at any visit. If complete polypoidal regression is present, defer the treatment and follow-up monthly with OCT monitoring in year 1, and bimonthly in year 2.
- Photodynamic therapy can be applied at 1 year, if persistent fluid on OCT is identified despite continuous intravitreous aflibercept injections.
Investigations at each visit
- Visual acuity measurement, color fundus photography (CFP), and SD-OCT will be performed at each visit
- Fundus fluorescein angiography (FA) and indocyanine green angiography (ICGA) will be performed at week 0 (baseline), 3, 6, 12, and 24 months, and at any time point showing a recurrence of disease activity in eye that previously shown complete polypoidal regression on ICGA, or at any time point an investigator suspect the presence of complete polypoidal regression based on OCT findings.
Definitions:
- Disease activity on color fundus photography is defined as a presence of new retinal or subretinal or sub-RPE hemorrhage
- Disease activity on OCT is defined as a presence of intraretinal or subretinal fluid or new pigment epithelial detachment
- Polypoidal regression is defined as complete absence of hyperfluorescent lesions in an area that previously had a polypoidal lesion on ICGA at baseline
- Partial polypoidal regression is defined as decrease of hyperfluorescent polypoidal lesions either in size or number or both in an area previously identified as a polypoidal lesion on ICGA at baseline
- Persistent or worsening polypoidal regression is defined as a persistent or enlargement in size and number of hyperfluorescent lesions in an area previously identified as a polypoidal lesion on ICGA at baseline
- Newly developed polypoidal lesion is defined as a presence of a polypoidal lesion not previously identified on ICGA at baseline
- Recurrent polypoidal lesion is defined as a polypoidal lesion in an area previously identified as polypoidal regression on ICGA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete polypoidal regression arm | Sham comparator | Other: Defer treatmentfollow up monthly with color fundus photography and OCT at each visit |
| incomplete polypoidal regression arm | Active comparator | Drug: Aflibercept Injection (2 mg/0.05 ml)continue treatment with aflibercept injection (treat and extend regimen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of ≥18 years
- Diagnosis of treatment-naïve PCV in either eye
- If any participant presents with bilateral PCV in which both eyes are eligible for the study, the eye with worse vision will be chosen as the study eye
Key exclusion criteria (8 listed)
- Presence of co-existing vision threatening conditions in the study eye, e.g., diabetic retinopathy, or retinal vascular occlusion
- Presence of ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in aflibercept
- Inability to obtain good quality imaging due to ocular media abnormalities
- Contraindicate for FFA or ICGA due to the following conditions:
- Not able to follow up according to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept Injection (2 mg/0.05 ml)Also: EyleaIntravitreal aflibercept injections (treat and extend regimen) | Drug | incomplete polypoidal regression arm |
| Defer treatmentFollow up with fundus photo and OCT every 4 weeks | Other | complete polypoidal regression arm |
Primary outcome
Interval of disease activity on color fundus photography or optical coherence tomography
Time frame: 1 to 24 months
* Disease inactivity on color fundus photography is defined as an absence of new retinal or subretinal or sub-RPE hemorrhage on color fundus photography compared with baseline * Disease inactivity on OCT is defined as an absence of intraretinal thickening or CME or subretinal fluid or PED or enlarging PED on OCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept Injection (2 mg/0.05 ml) and Defer treatment in people with Polypoidal Choroidal Vasculopathy, run by Chiang Mai University at 1 site in Thailand.
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 4 inclusion and 8 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interval of disease activity on color fundus photography or optical coherence tomography (time frame: 1 to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2021.