A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)
Stopped early · Phase 1/Phase 2
Conditions studied: Age Related Macular Degeneration, Choroidal Neovascular Membrane, Subfoveal Neovascular Age-Related Macular Degeneration, Macular Degeneration, Wet Age-Related Macular Degeneration
In brief
The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.
Key facts
- Study ID
- NCT01025232
- Run by
- David M. Brown, M.D.
- People needed
- 88
- Starts
- 2009-12-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2017-01-02
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Age ≥ 50 years
- For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study
- Although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch. A patient's primary care physician, obstetrician, or gynecologist should be consulted regarding an appropriate form of birth control.
- Ability and willingness to return for all scheduled visits and assessments
- Study eyes must meet the following criteria for entry into the SAVE trial:
- The last treatment with Ranibizumab is ≥ 28 days
- To have received at least 9 injections of Ranibizumab in the past 12 months
- Any CNVM lesion (Occult, Minimally Classic or Classic) (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-RPE fluid on Spectral Domain OCT) secondary to age-related macular degeneration.
- Best corrected visual acuity in the study eye, using e-ETDRS testing, between 20/25 and 20/320 (Snellen equivalent), inclusive.
- Only one eye will be enrolled in the Study. If both eyes are eligible study investigator will select the eye for entry.
- The total area of subretinal hemorrhage and fibrosis must comprise less than 50% of the total lesion.
- Clear ocular media and adequate pupillary dilation to permit good quality fundus imaging
You may not qualify if…
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Ocular Exclusion Criteria Prior Ocular Treatment
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye at a fluence equal to 100%, any fluence lower than 100% is permitted.
- Prior treatment with full or half fluence verteporfin PDT.
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs besides ranibizumab, or device implantation) in the study eye within the last 12 months.
- CNV Lesion Exclusion Characteristics
- Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either > 50% of the total area of the lesion or > 1 disc area (2.54 mm2) in size
- Subfoveal fibrosis or atrophy in the study eye
- CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Concurrent Ocular Conditions
- Retinal pigment epithelial tear involving the fovea in the study eye
- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either:
- Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 24-month study period.
- Active intraocular inflammation (grade trace or above) in the study 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 or absence of the posterior capsule in the study eye
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
- Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
- History of glaucoma-filtering surgery in the study eye
- History of corneal transplant in the study eye
- Concurrent Systemic Conditions (Exclusion)
Where it is running
- Greater Houston Retina Research — Houston, Texas, United States
- Greater Houston Retina Research — The Woodlands, Texas, United States
Full record on ClinicalTrials.gov
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