An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-26

Study Completion Date

2016-01-08

Brief Summary

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The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

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Detailed Description

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Conditions

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Choroidal Neovascularization Macular Edema Glaucoma, Neovascular Diabetic Retinopathy

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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ranibizumab

0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

Interventions

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ranibizumab

One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Active choroidal neovascularization (CNV)
* Active macular edema (ME)
* Rubeosis iridis/neovascular glaucoma.
* Proliferative diabetic retinopathy requiring vitrectomy.

Exclusion Criteria

* wet Age-related macular degeneration
* pathologic myopia
* pseudoxanthoma elasticum
* diabetic macular edema
* retinal vein occlusion
* \< 18 years of age
* History of hypersensitivity to ranibizumab
* Use of any systemic anti-angiogenic drugs 3 months before inclusion
* Women of child-bearing potential and Pregnant or nursing (lactating) women.
* Active or suspected ocular infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No