Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

QLT Inc.

Status and phase

Completed

Phase 2

Conditions

Choroidal Neovascularization

Macular Degeneration

Treatments

Drug: verteporfin

Drug: dexamethasone

Drug: ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00492284

BPD OCR 022

Details and patient eligibility

About

The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.

Enrollment

162 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Treatment naive for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye except for laser treatment outside the subfoveal area
Subfoveal CNV due to AMD
CNV must be = or >50 % of the entire lesion
All lesion composition types with a lesion greatest linear dimension (GLD) < 5400 microns (approximately = or <9 disc areas [DA])
Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320), inclusive

Exclusion criteria

Subfoveal geographic atrophy or subfoveal fibrosis of the study eye
Intraocular surgery within 3 months of enrollment
Inability to attend the protocol-required visits
Known allergies or hypersensitivity to any of the study treatments.
Other systemic diseases or active uncontrolled infections that would make subject a poor medical risk
Uncontrolled glaucoma, defined as (1)subject is on >1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration
If subject has had a stroke within the last year

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

162 participants in 4 patient groups

1/4 Fluence Triple Therapy

Experimental group

Description:

Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter

Treatment:

Drug: dexamethasone

Drug: verteporfin

Drug: ranibizumab

Drug: verteporfin

1/2 Fluence Triple Therapy

Experimental group

Description:

Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter

Treatment:

Drug: dexamethasone

Drug: verteporfin

Drug: ranibizumab

Drug: verteporfin

1/2 Fluence Double Therapy

Experimental group

Description:

Reduced-fluence Visudyne followed by Lucentis double therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter

Treatment:

Drug: verteporfin

Drug: ranibizumab