Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ranibizumab

Drug
Who is being recruted

Eye Diseases+8

+ Metaplasia

+ Neovascularization, Pathologic

Over 50 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2010
See protocol details

Summary

Principal SponsorPusan National University Hospital
Last updated: May 4, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01810042
Principal SponsorPusan National University Hospital
Last updated: May 4, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

49 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesMetaplasiaNeovascularization, PathologicPathologic ProcessesRetinal DegenerationRetinal DiseasesPathological Conditions, Signs and SymptomsUveal DiseasesChoroid DiseasesMacular DegenerationChoroidal Neovascularization

Criteria

4 inclusion criteria required to participate
Area of CNV clearly visible in ICGA is more than half of the total CNV area
Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area
Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
age >= 50
12 exclusion criteria prevent from participating
Blocked fluorescence in ICGA is more than half of the total CNV area
CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc)
Disciform scar
History of hypersensitivity to ranibizumab treatment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Pusan National University Hospital

Busan, South KoreaOpen Pusan National University Hospital in Google Maps

Haeundae Baik Hospital

Busan, South Korea
Completed2 Study Centers