CompletedPhase 4

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

South Korea20 participantsStarted 2016-03-03

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
✓. Age equal to or older than 50 years.
✓. 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)

Exclusion criteria

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

What they're measuring

Changes of a pigment epithelial detachment (PED)

Timeframe: Baseline and 6 months

Changes of a pigment epithelial detachment (PED)

Timeframe: Baseline and 6 months

Changes of subretinal fluid (SRF)

Timeframe: Baseline and 6 months

Changes of subretinal fluid (SRF)

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT02944227

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-16

View on ClinicalTrials.gov More Wet Macular Degeneration trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
✓. Age equal to or older than 50 years.
✓. 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)

Exclusion criteria

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