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

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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)

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

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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