Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Exudative Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810042
• Other study ID #: ??20120178
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2013
• Last updated: March 9, 2014
• Start date: October 2010
• Est. completion date: February 2013

Study information

• Verified date: March 2014
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Exudative Age-related Macular Degeneration
• Macular Degeneration
• Neovascularization, Pathologic
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Baik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Hospital	Novartis

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View Citation

Spaide RF. Rationale for combination therapies for choroidal neovascularization. Am J Ophthalmol. 2006 Jan;141(1):149-56. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	Lesion Size of CNV	Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.	6 months	No
Secondary	Visual Acuity	Visual acuity is measured using ETDRS chart, and correlation with caliber of CNV is assessed.	6 months	No
Secondary	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.	6 months	No