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

Novartis

Status and phase: Completed; Phase 3

Conditions: Choroidal Neovascularization; Macular Edema; Glaucoma, Neovascular; Diabetic Retinopathy

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01908816

CRFB002GFR02

Details and patient eligibility

About

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

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

ranibizumab

Experimental group

Description:

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

Treatment:

Drug: ranibizumab