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

August 10, 2016 updated by: Seoul National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age equal to or older than 50 years
  2. Insufficient responder to ranibizumab Tx
  3. ICGA-confirmed PCV
  4. BCVA letter score of 73 to 24 using Early Treatment of Diabetic Retinopathy Study charts
  5. Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion Criteria:

  1. Prior treatment with other anti-VEGF treatments in the study eye.
  2. Prior treatment with other anti-VEGF treatments within 3 months prior to Visit 1 in the non-study eye.
  3. Prior treatment with verteporfin within 6 months prior to Visit 1 in the study eye.
  4. Prior treatment with verteporfin within 7 days prior to Visit 1 in the non-study eye.
  5. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  6. Previous submacular surgery in the study eye
  7. A history of angioid streaks, presumed ocular histoplasmosis syndrome, or pathologic myopia
  8. Experienced RPE tear, retinal detachment, macular hole, or uncontrolled glaucoma
  9. Previous participation in a clinical trial involving anti-angiogenic drugs
  10. Intraocular surgery: 2 months before Visit 1 in the study eye.
  11. Previous participation in any studies of investigational drugs
  12. Administration of periocular, intravitreal, or systemic corticosteroid in the previous 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: combination Tx
combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6)
Procedure: PDT
PDT and ranibizumab
Drug: ranibizumab PRN
ranibizumab PRN
Other Names:
  • Lucentis
Other: mono Tx
Ranibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6)
Drug: Ranibizumab
Ranibizumab
Other Names:
  • Lucentis
Drug: ranibizumab PRN
ranibizumab PRN
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Novartis

Investigators

  • Principal Investigator: Jangwon Heo, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002AKR16T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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