Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Wet Macular Degeneration

Treatments: Drug: Lucentis

Study type: Interventional

Funder types: Other

Identifiers

NCT02944227

H-1512-107-728

Details and patient eligibility

About

The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy.

Full description

PEDs occur in up to 62% of eyes with advanced AMD. Numerous treatment options have been employed for PEDs in AMD, including laser therapies and intravitreal injections of anti-VEGF antibodies. However, eyes with PEDs were excluded from the larger clinical trials that used macular laser, photodynamic therapy, or ranibizumab to treat neovascular AMD; therefore, the efficacy of such options is still unclear for eyes with PEDs in neovascular AMD. Additionally, PED lesions have been reported to show less morphological and functional response to anti-VEGF monotherapy than eyes with other CNV lesions subtypes.

Based on the generally poor prognosis of PEDs and the lack of sufficient data in the literature regarding the effectiveness of fixed monthly dosing of Lucentis® (Ranibizumab) therapy, the investigators designed a prospective study to evaluate the effect of intensive fixed monthly dosing of Ranibizumab for the treatment of SRF associated with PED in neovascular AMD which is persistent to previous anti-VEGF monotherapy.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.

2. Age equal to or older than 50 years.

3. Presence of SRF associated with PED in neovascular AMD (proven with OCT FA, and ICG) which is persistent despite consecutive anti-VEGF injections for at least 9 months (3 initial loading doses with 4 week interval followed by PRN regimen)

   • A "persistent PED" is defined as a subject with < 50% reduction or increase in PED height

Key exclusion criteria

1. Administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye
2. Prior treatment with photodynamic therapy in the study eye
3. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
4. Previous submacular surgery in the study eye
5. History of vitrectomy in the study eye
6. Epiretinal membranes (ERM)
7. Submacular hemorrhage or fibrosis within 50% of entire PED.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Lucentis

Experimental group

Description:

Lucentis fixed treatment

Treatment:

Drug: Lucentis