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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-03

Study Completion Date

2017-08-21

Brief Summary

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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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Detailed Description

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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.

Conditions

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Wet Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lucentis

Lucentis fixed treatment

Group Type EXPERIMENTAL

Lucentis

Intervention Type DRUG

Lucentis fixed-treatment arm

Interventions

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Lucentis

Lucentis fixed-treatment arm

Intervention Type DRUG

Other Intervention Names

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Ranibizumab

Eligibility Criteria

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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

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No