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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02864472
Recruitment Status : Unknown
Verified August 2016 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Procedure: PDT Drug: Ranibizumab Drug: ranibizumab PRN Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Comparison of Early Intervention of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV Patients With Initial Loading Dose
Study Start Date : September 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
combination Tx
combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6)
Procedure: PDT
PDT and ranibizumab

Drug: ranibizumab PRN
ranibizumab PRN
Other Name: Lucentis

mono Tx
Ranibizumab (at 4 weeks interval) *3 (M0-2) + ranibizumab PRN (M3-6)
Drug: Ranibizumab
Ranibizumab
Other Name: Lucentis

Drug: ranibizumab PRN
ranibizumab PRN
Other Name: Lucentis




Primary Outcome Measures :
  1. Change in central retinal thickness [ Time Frame: after 6month ]
    Change in central retinal thickness measured by OCT


Secondary Outcome Measures :
  1. Change of ETDRS BCVA [ Time Frame: after 6month ]
    Change of ETDRS BCVA from baseline to 26 weeks and time course of it



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864472


Contacts
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Contact: Jangwon Heo, MD 82-2-2072-2438 hjw68@snu.ac.kr
Contact: Serang Choi, MD 82-2-2072-2953 icaol@hanmail.net

Sponsors and Collaborators
Seoul National University Hospital
Novartis
Investigators
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Principal Investigator: Jangwon Heo, MD Seoul National University Hospital

Publications of Results:
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

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02864472    
Other Study ID Numbers: CRFB002AKR16T
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents