Symtomatic Macular Polypoidal Choroidal VasculopathyPhase 4NCT02860858
Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)
A Phase 4 study testing Intravitreous aflibercept injection in people with Symtomatic Macular Polypoidal Choroidal Vasculopathy, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symtomatic Macular Polypoidal Choroidal Vasculopathy
- What is being tested?
- Intravitreous aflibercept injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 30 Dec 2016to 31 Dec 2018
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female >/= 18 years
- Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy
- BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters
Who cannot join
- Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
- Study eye:
- Active ocular inflammation or infection (ocular or periocular)
- Uncontrolled intraocular hypertension or glaucoma (IOP> 30 mmPIg) despite treatment with anti-glaucoma medication
- Predominantly-scarred PCV lesions
- Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period
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- Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
- Prior treatment with any anti-VEGF compound or any investigational treatment
- Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.
- Being tested
- Intravitreous aflibercept injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreous aflibercept injectionBiological
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Experimental | Not described Receives: Biological: Intravitreous aflibercept injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start30 Dec 2016
- Primary completion30 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symtomatic Macular 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860858
- Sponsor's protocol ID
- 18265_CREC032/59BPs
- Status last verified
- May 2018
- First submitted
- 4 Jul 2016
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)
- ClinicalTrials.gov ID
- NCT02860858
- Acronym / sponsor ID
- 18265_CREC032/59BPs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Experimental | Biological: Intravitreous aflibercept injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female >/= 18 years
- Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy
- BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters
Key exclusion criteria (9 listed)
- Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
- Active ocular inflammation or infection (ocular or periocular)
- Uncontrolled intraocular hypertension or glaucoma (IOP> 30 mmPIg) despite treatment with anti-glaucoma medication
- Predominantly-scarred PCV lesions
- Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period
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 |
|---|---|---|
| Intravitreous aflibercept injection | Biological | Aflibercept |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravitreous aflibercept injection in people with Symtomatic Macular Polypoidal Choroidal Vasculopathy, run by Department of Medical Services Ministry of Public Health of Thailand 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 23 Oct 2020. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (BCVA) (time frame: 2 years). 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 23 Oct 2020.