Status:
COMPLETED
Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD
Lead Sponsor:
Lpath, Inc.
Conditions:
Exudative Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis, Avastin or Eylea in subjects with wet Age-related Macula...
Detailed Description
The study will be conducted in subjects who qualify as "sub-responders" to Lucentis, Avastin or Eylea meaning that each subject has (i) residual subretinal or intra-retinal fluid observed on Cirrus or...
Eligibility Criteria
Inclusion
- ≥50 years of age with a diagnosis of wet AMD
- Subjects who have received 3 injections of Lucentis or Avastin or Eylea within 12 months prior to screening
- Active subfoveal CNV secondary to AMD (leakage on FA)
- Presence of residual subretinal or intraretinal fluid on Cirrus or Spectralis SDOCT
- SDOCT in the 1 mm central macular subfield on the retinal map analysis of ≥250 μm at screening
- ETDRS BCVA of ≥25 and ≤73 letters (approximately 20/320 and 20/40 on the Snellen scale) at screening and on Day 0
- In the fellow eye, ETDRS BCVA of 20/400 or better
- Subject with serous pigment epithelial detachment (PED) (any part of which may be subfoveal) with intraretinal and/or subretinal fluid may be included
Exclusion
- Most recent IVT injection of Lucentis or Avastin fewer than 28 days and more than 65 days prior to screening
- Most recent IVT injection of Eylea fewer than 42 days and more than 79 days prior to screening
- Previous photodynamic therapy (PDT) or Macugen® at any time point
- Focal thermal laser or grid laser within 3 months prior to Day 0
- Use of IVT, subtenon or subconjunctival steroids within 3 months prior to Day 0
- Use of topical ophthalmic corticosteroids 2 weeks prior to Day 0
- Intraocular surgery, including cataract surgery, and / or laser of any type within 3 months prior to Day 0 or anticipated need for ocular surgery or ophthalmic laser treatment during the study period
- Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
- Retinal total lesion size \>12 disc areas (30.5 mm2), including blood, scars and neovascularization as assessed by FA in the study eye
- Presence of a fibrovascular PED extending underneath the center of the fovea
- Presence of retinal angiomatous proliferation (RAP) lesions
- Presence of polypoidal choroidal vasculopathy (PCV) (if suspected, Indocyanine Green Angiography (ICG) should be performed at the discretion of the Investigator)
- Subretinal hemorrhage in the study eye if any of the following is true: (i) the subretinal hemorrhage represents 50% or more of the total lesion area; (ii) subfoveal blood is 1 or more disc areas in size (iii) subfoveal blood where the fovea is surrounded by less than 270 degrees of visible CNV on FA
- Scar or fibrosis making up \>50% of total lesion area in the study eye
- Anatomic damage to the center of the fovea including fibrosis, scarring or atrophy
- History of a retinal pigment epithelial tear
- History of vitreous hemorrhage within 4 weeks prior to screening in the study eye
- Clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye
- Uncontrolled glaucoma defined as: (i) as intraocular pressure ≥25 mmHg despite treatment with anti glaucoma medication in the study eye or (ii) by the Investigator
- Prior trabeculectomy or other filtration surgery in the study eye (prior laser trabeculoplasty is allowed)
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01414153
Start Date
August 1 2012
End Date
June 1 2015
Last Update
October 17 2016
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Retina Consultants of Arizona
Peoria, Arizona, United States, 85381
2
Retina Consultants of Arizona
Phoenix, Arizona, United States, 85014
3
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
4
Retina Centers, P.C.
Tucson, Arizona, United States, 85704