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OpenTrials
Completed

NCT Number: NCT01908816

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

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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Key information

Conditions

Choroidal Neovascularization Cardiovascular Diseases Choroid Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glaucoma Glaucoma, Neovascular Macular Degeneration Macular Edema Metaplasia Neovascularization, Pathologic Ocular Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Bobigny, Seine Saint Denis, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

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

Primary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: 24 months

    Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.

Secondary outcomes

  1. Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)

    Time frame: 3 months, 12 months

    BCVA change for diseases affecting the macular area either through CNV or ME. BCVA is tested using the ETDRS (Early Treatment Diabetic Retinopathy Study), the Snellen or Monoyer scales. The three scales are designed to measure visual acuity. ETDRS score is expressed in letter, Snellen and Monoyer score in fraction. BCVA assessment is presented in ETDRS after conversion if collected in Snellen or Monoyer. (Monoyer converted to Snellen = 2 x (Monoyer fraction) and Snellen converted to approximate ETDRS letters = 1x log(Snellen fraction). ETDRS letter score was transformed in logMAR unit for statistical analysis (- LogMAR = -(ETDRS-85)/50). The worse ETDRS letter score is 0 (logMAR 2.3) and the best ETDRS letter score is 100 (logMAR -0.3).

  2. Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma

    Time frame: 3 month, 12 month

    The extent of iris neovascularization was assessed by iris photography and graded using the "Teich and Walsh grading system". This grading system measures the number of quadrant at iris pupillary zone or iris ciliary zone where iris neovascularization (NV) is observed.

    Grade 0 = "No iris vascularization", Grade 1= Less than 2 quadrants of NV at iris pupillary zone, Grade 2 = More than 2 quadrants of NV at iris pupillary zone, Grade 3 =Grade 2 + less than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae; Grade 4 =More than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae)

  3. Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy

    Time frame: 3 months, 12 month

    Occurrence of postoperative vitreous cavity hemorrhage

  4. Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"

    Time frame: 3 months, 12 month

    CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area

  5. Proportion of Patients With Angiographic Leakage

    Time frame: 3 months, 12 month

    Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 3. Also any decreases of angiographic leakage was counted between baseline and 3 month.

  6. Ranibizumab Injection

    Time frame: 3 months, 12 month

    Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: ECLIPSE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2013
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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