Age-related Macular DegenerationPhase 4NCT02864472
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose
A Phase 4 study testing PDT, Ranibizumab and ranibizumab PRN in people with Age-related Macular Degeneration, run by Seoul National University Hospital.
Trial summary
The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- PDT, Ranibizumab and ranibizumab PRN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age equal to or older than 50 years
- Insufficient responder to ranibizumab Tx
- ICGA-confirmed PCV
- BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
Who cannot join
- Prior treatment with other anti-VEGF treatments in the study eye.
- Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye.
- Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye.
- Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye.
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- Previous submacular surgery in the study eye
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- A history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia
- Experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma
- Previous participation in a clinical trial involving anti-angiogenic drugs
- Intraocular surgery: 2 months before Visit 1 in the study eye.
- Previous participation in any studies of investigational drugs
- Administration of periocular, intravitreal, or systemic corticosteroid in the previous 3 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Early Intervention of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV Patients With Initial Loading Dose
The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.
Read the detailed description
PCV is generally recognized as a subtype of wet AMD characterized by the presence of aneurysmal orange-red polypoidal lesions with or without branching vascular network (BVN) in the choroidal vasculature as observed on indocyanine angiography (ICGA), representing 13% to 54.7% of newly diagnosed patients with neovascular AMD. Fifty percent of PCV had persistent leakage or recurrent bleeding with poor visual outcome, if left untreated.
And in the EVEREST study has shown that synergistic effects of anti-VEGF and vPDT combination: vPDT strongly regress polyp and anti-VEGF control to up-regulation of VEGF induced by vPDT compared to ranibizumab monotherapy in newly diagnosed PCV patients. Additionally, combination offers an opportunity for individualized treatment with potentially fewer treatments and less costs.
Therefore, the aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.
- Conditions
- Age-related Macular Degeneration
- Being tested
- PDT, Ranibizumab, ranibizumab PRN
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDTProcedure or surgery
PDT and ranibizumab
RanibizumabDrug
Also called Lucentis
Ranibizumab
ranibizumab PRNDrug
Also called Lucentis
ranibizumab PRN
| Study group | Role | What they receive |
|---|---|---|
| combination Tx | Other | combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6) Receives: Procedure: PDT; Drug: ranibizumab PRN |
| mono Tx | Other | Ranibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6) Receives: Drug: Ranibizumab; Drug: ranibizumab PRN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central retinal thickness
Change in central retinal thickness measured by OCT
Measured: after 6month
Secondary outcomes (1)
Change of ETDRS BCVA
Change of ETDRS BCVA from baseline to 26 weeks and time course of it
Measured: after 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Jangwon Heo, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864472
- Sponsor's protocol ID
- CRFB002AKR16T
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
1. Wong RLM et al. J Ophthalmol Vis Res 2013;8:359-71. 2. Koh A et al. Retina 2013;33:686-716 3. Nakashizuka H et al. Invest Ophthalmol Vis Sci 2008;49:4729-37 4. Gomi F, Tano Y Curr Opin Ophthalmol 2008;19:208-12 5. Honda S et al. Ophthalmologica 2014;231:59-74 6. Maruko E et al. Am J Ophthalmol 2007;144:15-22 7. Byeon S et al. Jpn J Ophthalmol 2008;52:57-62 8. Uyama M et al. Am J Ophthalmol 2002;133:639-48
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Intervention of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV Patients With Initial Loading Dose
- ClinicalTrials.gov ID
- NCT02864472
- Acronym / sponsor ID
- CRFB002AKR16T
- Conditions
- Age-related Macular Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 12 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.
The aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.
Detailed description
PCV is generally recognized as a subtype of wet AMD characterized by the presence of aneurysmal orange-red polypoidal lesions with or without branching vascular network (BVN) in the choroidal vasculature as observed on indocyanine angiography (ICGA), representing 13% to 54.7% of newly diagnosed patients with neovascular AMD. Fifty percent of PCV had persistent leakage or recurrent bleeding with poor visual outcome, if left untreated.
And in the EVEREST study has shown that synergistic effects of anti-VEGF and vPDT combination: vPDT strongly regress polyp and anti-VEGF control to up-regulation of VEGF induced by vPDT compared to ranibizumab monotherapy in newly diagnosed PCV patients. Additionally, combination offers an opportunity for individualized treatment with potentially fewer treatments and less costs.
Therefore, the aim of this study is to compare the efficacy of early intervention of PDT combination compared with consecutive monthly treatment of intravitreal ranibizumab injections in PCV patients showing insufficient response with initial loading dose.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination Tx | Other | Procedure: PDT, Drug: ranibizumab PRNcombination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6) |
| mono Tx | Other | Drug: Ranibizumab, Drug: ranibizumab PRNRanibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or older than 50 years
- Insufficient responder to ranibizumab Tx
- ICGA-confirmed PCV
- BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
Key exclusion criteria (12 listed)
- Prior treatment with other anti-VEGF treatments in the study eye.
- Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye.
- Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye.
- Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye.
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
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 |
|---|---|---|
| PDTPDT and ranibizumab | Procedure or surgery | combination Tx |
| RanibizumabAlso: LucentisRanibizumab | Drug | mono Tx |
| ranibizumab PRNAlso: Lucentisranibizumab PRN | Drug | combination Tx, mono Tx |
Primary outcome
Change in central retinal thickness
Time frame: after 6month
Change in central retinal thickness measured by OCT
1 secondary outcome
Change of ETDRS BCVA
Time frame: after 6month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Results publication1. Wong RLM et al. J Ophthalmol Vis Res 2013;8:359-71. 2. Koh A et al. Retina 2013;33:686-716 3. Nakashizuka H et al. Invest Ophthalmol Vis Sci 2008;49:4729-37 4. Gomi F, Tano Y Curr Opin Ophthalmol 2008;19:208-12 5. Honda S et al. Ophthalmologica 2014;231:59-74 6. Maruko E et al. Am J Ophthalmol 2007;144:15-22 7. Byeon S et al. Jpn J Ophthalmol 2008;52:57-62 8. Uyama M et al. Am J Ophthalmol 2002;133:639-48
- Individual participant dataSharing planned: Undecided
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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.
Jangwon Heo, MD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PDT, Ranibizumab and ranibizumab PRN in people with Age-related Macular Degeneration, run by Seoul National University Hospital.
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 5 inclusion and 12 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 12 Aug 2016. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jangwon Heo, MD (82-2-2072-2438, hjw68@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central retinal thickness (time frame: after 6month). 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 NCT02864472, which also lists 1 linked publication.
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 12 Aug 2016.