Age-related Macular Degeneration
Conditions
Keywords
age-related macular degeneration (AMD), choroidal neovascularization membrane(CNVM), ranibizumab, anti-vascular endothelial growth factor, electrophysiology, electroretinography
Brief summary
Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.
Detailed description
The functional changes of the retina can be recorded by an electroretinography (ERG).
Interventions
DRUGranibizumab
A single dose of 0.5 mg ranibizumab injected intravitreally.
Sponsors
Prince of Songkla University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 45 years and above * Clinical diagnosis of wet AMD * First injection of ranibizumab protocol * Best corrected visual acuity 20/32 - 20/320 * Consent form obtained
Exclusion criteria
* Previously treated wet AMD patients * Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc. * Pregnancy * History of seizure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Height (Amplitude) of Multifocal ERG Signal | baseline, 3 months | Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data. |
| Time to Response (Implicit Time) of Multifocal ERG Signal | baseline, 3 months | Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complication | 1 month | For instance, Endophthalmitis, retinal detachment |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab Group Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Ranibizumab Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age Continuous | 66.5 years STANDARD_DEVIATION 9.22 |
| Region of Enrollment Thailand | 26 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Height (Amplitude) of Multifocal ERG Signal
Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.
Time frame: baseline, 3 months
Population: Analysis was per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Group | Height (Amplitude) of Multifocal ERG Signal | 2.859 nanovolt/degree^2 | Standard Deviation 1.085 |
Comparison: Comparing pre-operative data with postoperative data in terms of changes in amplitude height and implicit time.p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Time to Response (Implicit Time) of Multifocal ERG Signal
Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.
Time frame: baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab Group | Time to Response (Implicit Time) of Multifocal ERG Signal | 31.621 millisecond | Standard Deviation 3.563 |
Secondary
Postoperative Complication
For instance, Endophthalmitis, retinal detachment
Time frame: 1 month