Trial Outcomes & Findings for Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab (NCT NCT01810042)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

6 months

Results posted on

2016-05-04

Participant Flow

Total 53 patients were screened and 49 patients were enrolled from Oct 2010 to Feb 2013 in Pusan National University Hospital and Inje Baik Haeundae Hospital.

This study has a single arm, and there was no assignment process.

Participant milestones

Participant milestones
Measure	Ranibizumab Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Overall Study STARTED	49
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranibizumab Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Overall Study Lost to Follow-up	10

Baseline Characteristics

Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab n=31 Participants Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment Korea, Republic of	31 participants n=5 Participants
Median visual acuity (ETDRS)	46 ETDRS letter n=5 Participants
Central subfield macular thickness (um)	317 micrometer n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Of 31 patients included in the baseline analysis, 7 patients had the thickest vessels under limitation of measurement.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab n=24 Participants Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Caliber of Choroidal New Vessel (CNV)	43.53 micrometer Interval 28.79 to 99.4

SECONDARY outcome

Timeframe: 6 months

Population: Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.

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

Outcome measures

Outcome measures
Measure	Ranibizumab n=31 Participants Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Lesion Size of CNV	3.03 square milimeter Interval 0.07 to 18.09

SECONDARY outcome

Timeframe: 6 months

Population: Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab n=31 Participants Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Visual Acuity in ETDRS Letters	69 ETDRS letters Interval 2.0 to 90.0

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.

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.

Outcome measures

Outcome measures
Measure	Ranibizumab n=31 Participants Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Visual Acuity Changes	12.5 ETDRS letters Interval -36.0 to 90.0

Adverse Events

Ranibizumab

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ranibizumab n=49 participants at risk Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Nervous system disorders Cerebral infarction	2.0% 1/49 • Number of events 1
Gastrointestinal disorders Liver cirrhosis	2.0% 1/49 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Ji Eun Lee

Pusan National University Hospital

Phone: +82-51-240-7957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place