Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments

Clement K. Chan

Status and phase: Completed; Phase 1

Conditions: Retinal Pigment Epithelial Detachment

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00749021

FVF4332s

Details and patient eligibility

About

This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.

Enrollment: 40 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is 50 years or older
• Patient is willing to participate in this study and to follow the criteria and protocol of this study.
• Patient is not involved with another clinical trial.
• Ability to understand the informed consent and willingness to sign the consent.
• Presence of a submacular vascularized or fibrovascular PED. Central foveal involvement by the PED or the CNV due to age related macular degeneration.
• PED less than or equal to 12 disc area in size
• BCVA with ETDRS of greater than or equal to 19 letters and less than or equal to 69 letters (20/400 to 20/40)
• Central 1-mm foveal thickness of greater than or equal to 250 microns on OCT.
• Greatest linear diameter of the submacular hemorrhage needs to be less than 50% of the entire PED.
• Submacular fibrosis needs to be less than 50% of the entire PED.
• Sufficiently clear media (cornea, anterior chamber, lens, vitreous) for OCT, FA, and FP.
• Intraocular pressure of 25 mm or less in the study eye, with or without use of ocular hypotensive agents.

Exclusion criteria

• Pregnancy or lactation
• Premenopausal women not using adequate contraception
• Known serious allergies to ranibizumab, fluorescein dye, drug for pupillary dilation, topical anesthetic, sterilizing solution
• Contraindication to pupillary dilation in study eye
• Any condition (including inability to read visual acuity charts or language barrier) that may preclude patient's ability to comply with the study protocol requirements
• Presence of any advanced systemic condition or endstage disease, advanced Alzheimer syndrome, endstage cancer, etc., which will likely prevent patient from completing study.
• Previous therapeutic radiation in the region of the study eye.
• Prior anti-vascular endothelial factor therapy within 30 days.
• More than 3 sessions of prior anti-VEGF therapy.
• More than 1 prior photodynamic therapy (PDT)
• Prior triamcinolone in the past 6 months or dexamethasone in the past 1 month.
• Prior retinal pigment epithelial (RPE) tear in study eye.
• Prior ocular surgery (except YAG laser capsulotomy) for study eye within past 90 days.
• Anticipated ocular surgery (except YAG laser capsulotomy) for the next 12 months.
• Prior therapy for AMD (except minerals and vitamins), including laser, within the past 30 days.
• Prior intraocular or periocular corticosteroid therapy within the past 120 days
• Prior vitrectomy
• Presence of any causes of CNV and PED other than due to AMD.
• Presence of any substantial ocular disease (other than CNV and PED) that may compromise vision in the study eye and/or confound interpretation of the date; e.g. substantial cataracts, concomitant diabetic retinopathy affecting the macula, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
• Presence of ocular disease other than AMD affecting study eye, i.e. presumed ocular histoplasmosis syndrome, angioid streaks, pathologic myopia (spherical equivalent of greater than or equal to -8 diopters of myopia or axial length of greater than or equal to 25 mm), choroidal rupture, multifocal choroiditis, etc.
• Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at screening or Day 0.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Regimen 1

Active Comparator group

Description:

Intravitreal injection of Ranibizumab monthly for 12 months.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Regimen 2

Active Comparator group

Description:

Intravitreal injection of ranibizumab for 4 months (at Day 0, Month 1, Month 2, and Month 3) followed by by treatments on predefined re-treatment criteria.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Regimen 3

Active Comparator group

Description:

Intravitreal injection of Ranibizumab 2.0mg monthly for 12 months

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Regimen 4

Active Comparator group

Description:

Intravitreal injection 2.0mg ranibizumab for 4 months (at Day 0, Month 1 and Month 2, and Month 3) followed by PRN treatments on pre-defined re-treatment criteria

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab