Polypoidal Choroidal VasculopathyNCT01360151
Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy
A study testing ranibizumab(Lucentis), verteporfin(Visudyne) in people with Polypoidal Choroidal Vasculopathy, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- ranibizumab(Lucentis), verteporfin(Visudyne)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to May 2011
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female patients ≥ 45yrs of age
- Best corrected Visual acuity 20/30 to 20/320 Snellen equivalent using ETDRS chart measured at 4 meters
- Signed written informed consent
- Evidence of Polypoidal choroidal vasculopathy , active in disease activity.
- Presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography
- Confirmed to be active in disease activity by fluorescein angiography
Show all 9Show fewer
- The total lesion must have the greatest linear dimension less than 5400 microns ( ~9 MPS Disc Areas ) as delineated by indocyanine green angiography
- Had not been treated in the past
- Patients willing and able to comply with all study procedures
Who cannot join
- Previous history of laser photocoagulation,photodynamic therapy,anti VEGF therapy, submacular surgery in the study eye
- Have known hypersensitivity to Visudyne® and Lucentis™
- Previous treatment with external-beam radiation therapy or transpupillary thermotherapy
- History of vitrectomy
- Intraocular surgery,yttrium aluminum garnet(YAG) laser< 1month before day 0
- Additional eye disease that could compromise visual acuity
Show all 17Show fewer
- Ocular inflammation
- Vitreous hemorrhage
- Uncontrolled glaucoma
- Current use or of likely need for systemic medications known to be toxic to the eye.
- Inability to obtain fluorescein angiography and indocyanine green angiography, due to media opacity, allergy to the dye or lack of venous access
- Are participating in another clinical study.
- Disciform scar
- Mental illness that precludes the patient from giving informed consent
- Patients who are considered potentially unreliable
- <Control group>
- -Age matched patients with cataract without other ocular diseases such as glaucoma, high myopia, ocular ischemic diseases, retinal disease, or with systemic diseases like diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Won Ki Lee
Seoul
Won Ki Lee, MD, PhD, 82-2-10-3265-1262, wklee@catholic.ac.kr
Mee Yon Lee, MD, 82-10-3230-1863, deenie@daum.net
About this study
This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.
Read the detailed description
To compare the effect of combination therapy of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy on aqueous humor vascular endothelial growth factor level in polypoidal choroidal vasculopathy patients to establish the vascular endothelial growth factor expression after photodynamic therapy and the direct effect of Lucentis™ on this increased vascular endothelial growth factor level. Additionally the investigators want to examine the vascular endothelial growth factor , tumor necrosis factor alpha, interleukin-2, interleukin-6 and interleukin-8 level of aqueous humor in symptomatic, active polypoidal choroidal vasculopathy patients.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- ranibizumab(Lucentis), verteporfin(Visudyne)
- Keywords
- VEGF (Vascular endothelial growth factor)
- 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.
ranibizumab(Lucentis), verteporfin(Visudyne)Drug
Also called ranibizumab(Lucentis) : 0.5mg/0.05ml, verteportin (Visudyne) : 15mg (6mg/m2)
ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection Receives: Drug: ranibizumab(Lucentis), verteporfin(Visudyne) |
| active comparator | Active comparator | Arm 2 : Treatment of verteporfin(Visudyne) Receives: Drug: ranibizumab(Lucentis), verteporfin(Visudyne) |
| normal control group | No intervention | Arm 3 : normal control group Receives: Drug: ranibizumab(Lucentis), verteporfin(Visudyne) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in cytokine levels at 1 week, 1 month and 3 month
- To compare the baseline level of cytokines in aqueous humor. polypoidal choroidal vasculopathy group(Arm A+Arm B) vs normal control group
- To compare the change of cytokine level of aqueous humor after combination treatment of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy.(1 week, 1 month, 3 month)
Measured: baseline, 1 week, 1 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360151
- Sponsor's protocol ID
- 1-Lee
- Status last verified
- Apr 2011
- First submitted
- 12 Apr 2011
- Last updated
- 30 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Humor Level of Cytokines in Polypoidal Choroidal Vasculopathy and Change of Cytokines After Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT01360151
- Acronym / sponsor ID
- 1-Lee
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- VEGF (Vascular endothelial growth factor)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 25 May 2011 (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.
This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.
Detailed description
To compare the effect of combination therapy of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy on aqueous humor vascular endothelial growth factor level in polypoidal choroidal vasculopathy patients to establish the vascular endothelial growth factor expression after photodynamic therapy and the direct effect of Lucentis™ on this increased vascular endothelial growth factor level. Additionally the investigators want to examine the vascular endothelial growth factor , tumor necrosis factor alpha, interleukin-2, interleukin-6 and interleukin-8 level of aqueous humor in symptomatic, active polypoidal choroidal vasculopathy patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: ranibizumab(Lucentis), verteporfin(Visudyne)Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection |
| active comparator | Active comparator | Drug: ranibizumab(Lucentis), verteporfin(Visudyne)Arm 2 : Treatment of verteporfin(Visudyne) |
| normal control group | No intervention | Drug: ranibizumab(Lucentis), verteporfin(Visudyne)Arm 3 : normal control group |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female patients ≥ 45yrs of age
- Best corrected Visual acuity 20/30 to 20/320 Snellen equivalent using ETDRS chart measured at 4 meters
- Signed written informed consent
- Evidence of Polypoidal choroidal vasculopathy , active in disease activity.
- Presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography
Key exclusion criteria (17 listed)
- Previous history of laser photocoagulation,photodynamic therapy,anti VEGF therapy, submacular surgery in the study eye
- Have known hypersensitivity to Visudyne® and Lucentis™
- Previous treatment with external-beam radiation therapy or transpupillary thermotherapy
- History of vitrectomy
- Intraocular surgery,yttrium aluminum garnet(YAG) laser< 1month before day 0
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 |
|---|---|---|
| ranibizumab(Lucentis), verteporfin(Visudyne)Also: ranibizumab(Lucentis) : 0.5mg/0.05ml, verteportin (Visudyne) : 15mg (6mg/m2)ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection | Drug | active comparator, experimental, normal control group |
Primary outcome
change from baseline in cytokine levels at 1 week, 1 month and 3 month
Time frame: baseline, 1 week, 1 month, 3 month
1. To compare the baseline level of cytokines in aqueous humor. polypoidal choroidal vasculopathy group(Arm A+Arm B) vs normal control group 2. To compare the change of cytokine level of aqueous humor after combination treatment of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy.(1 week, 1 month, 3 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
Related trials for Polypoidal Choroidal Vasculopathy
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
RecruitingPhase 3
Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
RecruitingPhase 3
Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy
Polypoidal Choroidal Vasculopathy (PCV), Age Related Macular Degeneration
Active, not recruitingPhase 1/2
Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
Neovascular (Wet) AMD
RecruitingPhase 4
Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)
Polypoidal Choroidal Vasculopathy
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 ranibizumab(Lucentis), verteporfin(Visudyne) in people with Polypoidal Choroidal Vasculopathy, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 9 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 30 May 2011. 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 South Korea. 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.
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?
change from baseline in cytokine levels at 1 week, 1 month and 3 month (time frame: baseline, 1 week, 1 month, 3 month). 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 30 May 2011.