Clinical trial NCT01189019: HiPED - High Dose Lucentis for Persistent Pigment Epithelial Detachments in Age-related Macular Degeneration
Official title: High Dose Lucentis for Persistent Pigment Epithelial Detachment in Neovascular Age-related Macular Degeneration - The HiPED Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Wet Macular Degeneration
Macular Degeneration
Retinal Pigment Epithelial Detachment
Keywords: ranibizumab
Wet macular degeneration
macular degeneration
PED
Retinal Pigment Epithelial Detachment
Lead sponsor: Pacific Eye Associates
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in visual acuity from baseline to 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Visual acuity from baseline to 6 months
timeFrame: 6 months
measure: Safety
timeFrame: 12 months
measure: % with > 15 ETDRS letter gain from baseline through 12 months
timeFrame: 12 months
measure: Change in OCT CST from baseline through 6 and 12 months
timeFrame: 12 months
measure: Time to recurrence of PED in PRN Arm
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Eye Associates
state: California
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
Study officials:
affiliation: Pacific Eye Associates / California Pacific Medical Center
name: Anne Fung, MD
role: PRINCIPAL_INVESTIGATOR
References: