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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.
A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other group will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. |
|
| Group II | Experimental | Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5 mg. given as an intraocular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Retreatments Over One Year | Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits. | 1 year |
| Number of Injections Over 12 Months |
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Inclusion Criteria:
Willingness to sign informed consent.
Age greater than 50.
Evidence of macular degeneration in the form of drusen in either eye.
Visual acuity of 20/25 to 20/800.
Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:
Total active lesion must be less than 12 disc areas in size. -
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Callanan, MD | Texas Retina Associates | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants & Research Foundation | Santa Barbara | California | 93103 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. |
| FG001 | Reduced Fluence PDT & Ranibizumab | Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I | Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. |
| BG001 | Group II |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Average age |
| 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 | The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. | Fifty-six participants completed the full 12 month study. Four subjects did not return for the 12 month visit. No patients terminated the study due to adverse events. | Posted | Number | percentage of participants | 1 year |
|
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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 | Group I | Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Callanan, MD | Texas Retina Associates | 817-261-9625 | dcallanan@texasretina.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D008679 | Metaplasia |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| verteporfin | Drug | Standard dosage of 6 mgs. / meter2 of body surface area given intravenously. |
|
|
Additional number of ranibizumab injections given in each group over the 12 months
| 1 year |
| Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity | 1 year |
| Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months | Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement | 1 year |
| Associated Retinal Consultants |
| Ann Arbor |
| Michigan |
| 49301 |
| United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percentage of Participants With Retreatments Over One Year | Number of days to retreatment outcome changed to frequency of retreatments at maintenance visits. | Posted | Number | % of subjects requiring additional injec | 1 year |
|
|
|
| Secondary | Number of Injections Over 12 Months | Additional number of ranibizumab injections given in each group over the 12 months | Posted | Mean | Standard Deviation | injections | 1 year |
|
|
|
| Secondary | Percentage of Subjects Gaining More Than 15 ETDRS Letters of Acuity | Posted | Number | percentage | 1 year |
|
|
|
| Secondary | Improvement in OCT (Optical Coherent Tomography) Foveal Thickness at 12 Months | Improvement in OCT (Optical coherent tomography) foveal thickness at 12 months/Number of microns in foveal thickness measurement | Posted | Mean | Standard Deviation | microns | 1 year |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Group II | Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |