HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration
Phase 2
Terminated
- Conditions
- Wet Macular DegenerationMacular DegenerationRetinal Pigment Epithelial Detachment
- Interventions
- Registration Number
- NCT01189019
- Lead Sponsor
- Anne Fung MD
- Brief Summary
In this fifth year of anti-VEGF therapy for neovascular AMD, retinal physicians are collecting groups of patients who either do not or only partially respond to anti-VEGF therapy. This study will evaluate the efficacy and safety of 2mg ranibizumab specifically for patients with fibrovascular PEDs that have not resolved following at least 6 consecutive injections of ranibizumab or bevacizumab over the previous 12 months. The investigators hypothesize that the 2mg dose will be able to completely eliminate the persistent PEDS in these patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Active or recurrent neovascular age-related macular degeneration involving the fovea on FA
- Presence of persistent fibrovascular pigment epithelial detachment on OCT following a minimum 6 previous treatments in previous 12 months with ranibizumab and/or bevacizumab. Patients may have received more than 12 months of anti-VEGF therapy.
- ETDRS Best Corrected Visual acuity 20/32 - 20/400
Exclusion Criteria
- Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD, Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) in study eye.
- Lesion Characteristics: Subfoveal fibrosis or atrophy in study eye, CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
- Concurrent Ocular Conditions: Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma), Any concurrent intraocular condition in the study eye (e.g., diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either, Require medical or surgical intervention during the 12-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 best corrected visual acuity over the 12-month study period, 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
- Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Aphakia or absence of the posterior capsule in the study eye unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure 30 mmHg despite treatment with anti-glaucoma medication)
Concurrent Systemic Conditions
- Pregnancy or premenopausal women not using adequate contraception The following are considered effective means of contraception: surgical sterilization; 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.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
Other
- Inability to dilate pupils sufficient for adequate fluorescein angiography
- Inability to comply with study or follow up procedures
Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy (positive pregnancy test)
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 - 2mg ranibizumab monthly ranibizumab 2mg ranibizumab monthly Group 2 - 2mg x 3 then PRN ranibizumab -
- Primary Outcome Measures
Name Time Method Mean change in visual acuity from baseline to 24 months 24 months Best corrected visual acuity on the ETDRS chart at 4 meters will be compared
- Secondary Outcome Measures
Name Time Method Visual acuity from baseline to 6 months 6 months BCVA on ETDRS will be compared from baseline to 6 months
Safety 12 months incidence and severity of ocular and non-ocular adverse events will be evaluated through 12 months
% with > 15 ETDRS letter gain from baseline through 12 months 12 months Change in OCT CST from baseline through 6 and 12 months 12 months Time to recurrence of PED in PRN Arm 12 months
Trial Locations
- Locations (3)
Pacific Eye Associates
🇺🇸San Francisco, California, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Tennessee Retina
🇺🇸Nashville, Tennessee, United States