Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

NCT ID: NCT01810042

Last Updated: 2016-05-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Exudative Age-related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

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

Interventions

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ranibizumab

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

Intervention Type DRUG

Other Intervention Names

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intravitreal injection of ranibizumab (Lucentis, Novartis)

Eligibility Criteria

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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.)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji Eun Lee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji Eun Lee, MH, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National Universtiy Hospital

Locations

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Pusan National University Hospital

Busan, , South Korea

Site Status

Haeundae Baik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 15177969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17021318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17021319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16386991 (View on PubMed)

Other Identifiers

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임상20120178

Identifier Type: -

Identifier Source: org_study_id

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