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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.
The functional changes of the retina can be recorded by an electroretinography (ERG).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | A single dose of 0.5 mg ranibizumab injected intravitreally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Height (Amplitude) of Multifocal ERG Signal | Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data. | baseline, 3 months |
| 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. | baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complication | For instance, Endophthalmitis, retinal detachment | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patama Bhurayanontachai, MD | Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17021318 | Background | 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. | |
| 17949673 | Background | Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, Schneider S, Acharya NR. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol. 2007 Dec;144(6):850-857. doi: 10.1016/j.ajo.2007.08.012. Epub 2007 Oct 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Height (Amplitude) of Multifocal ERG Signal | Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data. | Analysis was per protocol | Posted | Mean | Standard Deviation | nanovolt/degree^2 | baseline, 3 months | eyes | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Small number of participants
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patama Bhurayanontachai | Prince of Songkla University | 66-74-451380 | tpatama@hotmail.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| eyes |
|
|
|
| Secondary | Postoperative Complication | For instance, Endophthalmitis, retinal detachment | Not Posted | 1 month |
| 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. | Posted | Mean | Standard Deviation | millisecond | baseline, 3 months | eyes | Participants |
|
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| 0 |
| 26 |
| 0 |
| 26 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |