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Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Primary Purpose

Exudative Age-related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-related Macular Degeneration focused on measuring age-related macular degeneration, choroidal neovascularization, ranibizumab, indocyanine angiography

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Pusan National University Hospital
  • Haeundae Baik Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Caliber of Choroidal New Vessel (CNV)
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 Outcome Measures

Lesion Size of CNV
Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.
Visual Acuity in ETDRS Letters
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.
Visual Acuity Changes
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.

Full Information

First Posted
March 11, 2013
Last Updated
March 29, 2016
Sponsor
Pusan National University Hospital
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01810042
Brief Title
Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab
Official Title
A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration
Keywords
age-related macular degeneration, choroidal neovascularization, ranibizumab, indocyanine angiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ranibizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
intravitreal injection of ranibizumab (Lucentis, Novartis)
Intervention Description
0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Primary Outcome Measure Information:
Title
Caliber of Choroidal New Vessel (CNV)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lesion Size of CNV
Description
Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.
Time Frame
6 months
Title
Visual Acuity in ETDRS Letters
Description
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.
Time Frame
6 months
Title
Visual Acuity Changes
Description
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.
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Eun Lee, MH, PhD
Organizational Affiliation
Pusan National Universtiy Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Haeundae Baik Hospital
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
15177969
Citation
Wong TY, Knudtson MD, Klein R, Klein BE, Meuer SM, Hubbard LD. Computer-assisted measurement of retinal vessel diameters in the Beaver Dam Eye Study: methodology, correlation between eyes, and effect of refractive errors. Ophthalmology. 2004 Jun;111(6):1183-90. doi: 10.1016/j.ophtha.2003.09.039.
Results Reference
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PubMed Identifier
17021318
Citation
Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
Results Reference
background
PubMed Identifier
17021319
Citation
Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.
Results Reference
background
PubMed Identifier
16386991
Citation
Spaide RF. Rationale for combination therapies for choroidal neovascularization. Am J Ophthalmol. 2006 Jan;141(1):149-56. doi: 10.1016/j.ajo.2005.07.025.
Results Reference
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Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

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