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NCT Number: NCT01810042

Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.

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Key information

Conditions

Exudative Age-Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Haeundae Baik Hospital, Busan, South Korea

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About this study

For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures of CNV is investigated at baseline, 3 and 6 months using ICGA. Expected number of patients are 48 eyes from 4 centers, competitively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age >= 50
  • Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
  • Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area.
  • Area of CNV clearly visible in ICGA is more than half of the total CNV area.

Exclusion criteria

  • CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc)
  • Blocked fluorescence in ICGA is more than half of the total CNV area.
  • Disciform scar
  • Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months
  • Previous any treatment of photodynamic therapy or photocoagulation
  • Previous intraocular or periocular injection of steroid within 3 months
  • Previous intraocular surgery except cataract surgery
  • Vitreo-retinal interface disease on the macula
  • Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.)
  • Uncontrolled periocular or intraocular infection
  • History of hypersensitivity to ranibizumab treatment
  • Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)

Treatment and study plan

ranibizumab

Drug

0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.

Other names: intravitreal injection of ranibizumab (Lucentis, Novartis)

Primary outcomes

  1. Caliber of Choroidal New Vessel (CNV)

    Time frame: 6 months

    Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.

Secondary outcomes

  1. Lesion Size of CNV

    Time frame: 6 months

    Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.

  2. Visual Acuity in ETDRS Letters

    Time frame: 6 months

    Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.

  3. Visual Acuity Changes

    Time frame: baseline and 6 months

    Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline.

    Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Collaborators

  • Novartis

Registry information

Official study title

A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2013
Registry last updated
May 4, 2016

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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