Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related Macular Degeneration.
After exiting VGFT-OD 0910, patients will be enrolled into RANGE, a longterm extension trial evaluating the safety and efficacy of aflibercept IAI utilizing a "treat and extend" regimen. Using pre-specified re-treatment criteria, treatment intervals will be variable with dosing of the active treatment at least every 12 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept | Experimental | All patients will receive aflibercept 2.0mg intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Patients will receive Aflibercept 2.0mg intravitreal injection at all scheduled study visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Portion of patients who maintain vision (loss of < or = 5 letters ETDRS BCVA) from baseline to Year 1. | 1 Year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy in the study eye
Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either
Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Aphakia, ACIOL, or unstable PCIOL
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
Pregnant or breast-feeding women
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
Contraception is not required for men with documented vasectomy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William L. Clark, M.D. | Palmetto Retina Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Retina | Augusta | Georgia | 30909 | United States | ||
| Eye Surgical Associates |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 30, 2018 | |
| Reset | Sep 25, 2018 | |
| Release | Mar 19, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lincoln |
| Nebraska |
| 68506 |
| United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Retina Consultants Houston | Houston | Texas | 77030 | United States |
| Rocky Mountain Retina | Salt Lake City | Utah | 84107 | United States |
| Reset | Apr 12, 2019 |
| Release | Nov 12, 2019 |
| Reset | Dec 3, 2019 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 30, 2018 | Sep 25, 2018 | |||
| Mar 19, 2019 | Apr 12, 2019 | |||
| Nov 12, 2019 | Dec 3, 2019 |
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided