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

Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02864472
• Other study ID #: CRFB002AKR16T
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 4, 2016
• Last updated: August 10, 2016
• Start date: September 2016
• Est. completion date: January 2019

Study information

• Verified date: August 2016
• Source: Seoul National University Hospital
• Contact: Jangwon Heo, MD
• Phone: 82-2-2072-2438
• Email: hjw68[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Procedure:
• PDT
PDT and ranibizumab

Drug:
• Ranibizumab
Ranibizumab
• ranibizumab PRN
ranibizumab PRN

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Novartis

References & Publications (1)

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;23

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in central retinal thickness	Change in central retinal thickness measured by OCT	after 6month	Yes
Secondary	Change of ETDRS BCVA	Change of ETDRS BCVA from baseline to 26 weeks and time course of it	after 6month	Yes