Comparison of PDT Combination With Ranibizumab vs. Ranibi... | NCT02864472

Studies
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose

NCT02864472

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 12, 2016Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Age-related Macular Degeneration

Interventions

PDT
Ranibizumab
ranibizumab PRN

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Aug 4, 2016

First Submission Date that Met QC Criteria

Aug 10, 2016

First Posted Date

Aug 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2016

Last Update Posted Date

Aug 12, 2016Estimated

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
combination Tx	Other	combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6)	Procedure: PDT Drug: ranibizumab PRN
mono Tx	Other	Ranibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6)	Drug: Ranibizumab Drug: ranibizumab PRN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PDT	Procedure	PDT and ranibizumab	combination Tx
Ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in central retinal thickness	Change in central retinal thickness measured by OCT	after 6month

Secondary Outcomes

Measure	Description	Time Frame
Change of ETDRS BCVA	Change of ETDRS BCVA from baseline to 26 weeks and time course of it	after 6month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Jangwon Heo, MD	Contact	82-2-2072-2438		hjw68@snu.ac.kr
Serang Choi, MD	Contact	82-2-2072-2953		icaol@hanmail.net

Name	Affiliation	Role
Jangwon Heo, MD	Seoul National University Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
C008848	1-phenyl-3,3-dimethyltriazene
D000069579	Ranibizumab

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins