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

NCT ID: NCT02864472

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-01-31

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.

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

combination Tx

combination Tx(vPDT +ranibizumab) (M0) + ranibizumab PRN (M3-6)

Group Type: OTHER

PDT

Intervention Type: PROCEDURE

PDT and ranibizumab

ranibizumab PRN

Intervention Type: DRUG

ranibizumab PRN

mono Tx

Ranibizumab (at 4 weeks interval) \*3 (M0-2) + ranibizumab PRN (M3-6)

Group Type: OTHER

Ranibizumab

Intervention Type: DRUG

Ranibizumab

ranibizumab PRN

Intervention Type: DRUG

ranibizumab PRN

Interventions

PDT

PDT and ranibizumab

Intervention Type: PROCEDURE

Ranibizumab

Ranibizumab

Intervention Type: DRUG

ranibizumab PRN

ranibizumab PRN

Intervention Type: DRUG

Other Intervention Names

Lucentis; Lucentis

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jangwon Heo, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

Jangwon Heo, MD

Role: CONTACT

hjw68@snu.ac.kr

82-2-2072-2438

Serang Choi, MD

Role: CONTACT

icaol@hanmail.net

82-2-2072-2953

References

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

Reference Type: RESULT

Other Identifiers

CRFB002AKR16T

Identifier Type: -

Identifier Source: org_study_id