Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

March 29, 2016 updated by: Ji Eun Lee, Pusan National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 612-896
        • Haeundae Baik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.
Drug: ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Other Names:
  • intravitreal injection of ranibizumab (Lucentis, Novartis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Collaborators

Novartis

Investigators

  • Principal Investigator: Ji Eun Lee, MH, PhD, Pusan National Universtiy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 임상20120178

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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