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Completed

NCT Number: NCT02944227

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

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.

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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Key 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.

Treatment and study plan

Lucentis

Drug

Lucentis fixed-treatment arm

Other names: Ranibizumab

Primary outcomes

  1. Changes of a pigment epithelial detachment (PED)

    Time frame: Baseline and 6 months

    Maximum height

  2. Changes of a pigment epithelial detachment (PED)

    Time frame: Baseline and 6 months

    Maximum diameter

  3. Changes of subretinal fluid (SRF)

    Time frame: Baseline and 6 months

    Maximum height

  4. Changes of subretinal fluid (SRF)

    Time frame: Baseline and 6 months

    Maximum diameter

Secondary outcomes

  1. Change in best corrected visual acuity from baseline

    Time frame: Baseline and 6 months

  2. Changes in subfoveal thickness (SFT) measured by optical coherence tomography (OCT) from baseline

    Time frame: Baseline and 6 months

  3. The proportion of cases maintaining vision and also who gained ≥ 15 letters from baseline

    Time frame: Baseline and 6 months

  4. The proportion of cases having complete resolution of SRF associated with serous pigment epithelial detachment (PED)

    Time frame: Baseline and 6 months

  5. The proportion of cases having complete resolution of subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)

    Time frame: Baseline and 6 months

  6. The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with serous pigment epithelial detachment (PED)

    Time frame: Baseline and 6 months

  7. The proportion of cases having persistent or recurrent subretinal fluid (SRF) associated with fibrovascular pigment epithelial detachment (PED)

    Time frame: Baseline and 6 months

  8. The incidence of ocular adverse events

    Time frame: Through study completion, an average of 1 year

  9. The proportion of cases experiencing leakage from neovascular AMD lesions

    Time frame: Baseline and 6 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Efficacy of Fixed Monthly Dosing of Lucentis® (Ranibizumab) on Subretinal Fluid (SRF) Associated With Persistent Pigment Epithelial Detachment (PED) in Neovascular Age-related Macular Degeneration (AMD): A Pilot Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 25, 2016
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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