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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Age-related Macular Degeneration

Treatments: Drug: ranibizumab PRN; Procedure: PDT; Drug: Ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02864472

CRFB002AKR16T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

combination Tx

Other group

Description:

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

Treatment:

Procedure: PDT

Drug: ranibizumab PRN

mono Tx

Other group

Description:

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

Treatment:

Drug: Ranibizumab

Drug: ranibizumab PRN