Safety and Tolerability Study for Age-Related Macular Degeneration
This study has been completed.
Information provided by (Responsible Party):
Iconic Therapeutics, Inc.
First received: December 1, 2011
Last updated: February 4, 2015
Last verified: February 2015
Phase 1: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of hI-con1™ for subjects with Age-Related Macular Degeneration.
Phase 2: The purpose of this study is to evaluate the safety of 3 injections of hI-con1™ at 2 different dose levels.
Neovascular Age-Related Macular Degeneration
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 1 / 2 Trial to Investigate The Safety and Tolerability of Single and Repeated Doses of hI-CON1™ Following Administration by Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
Primary Outcome Measures:
- Safety and Tolerability [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Phase 1 is designed to evaluate the safety and tolerability of single ascending doses of hI-con1 and to determine the MTD that can be administered by intravitreal injection. Assessments that will be conducted are OCTs, FAs, Blood Pressure, Color Fundus, VA Acutiy, Labs, Ophthalmic exams, and IOPs. They will be occurring at screening through week 24.
- Safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Phase 2 is designed to evaluate the safety of 3 injections of hI-con1 using the MTD and one dosage level lower than the MTD or standard of care Lucentis administered by intravitreal injection. Assessments that will be conducted are OCTs, FAs, Blood Pressure, Color Fundus, VA Acutiy, Labs, Ophthalmic exams, and IOPs. They will be occurring at screening through week 24.
Secondary Outcome Measures:
- Efficacy [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
For both Phase 1 and Phase 2, preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus photography, fluorescein angiography and OCT.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
Phase 1- This is a dose escalation study (20µl, 50µl, or 100 µl)given at baseline and then the subject is followed up to week 24.
Phase 1: 20µl, 50µl, or 100µl per injection (in the eye) on Day 1 only
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Ocular Inclusion Criteria:
- Active choroidal neovascularization (CNV) associated with age-related macular degeneration, as evidenced on fluorescein angiography and OCT, with the following lesion characteristics:
- Subretinal hemorrhage if present < 50% of total lesion size
- During Phase 1, the 4th, 5th, and 6th subjects enrolled in each cohort must have total lesion area < 6 DA (total area of detachment) (15.24 mm2), of which at least 50% must be actively leaking, and 30% should be classic on the angiography as determined by a reading center, and no more than 3 prior injections of any therapy for the treatment of CNV.
- For Phase 2, total lesion area < 6 DA (total area of detachment) (15.24 mm2), of which at least 50% must be actively leaking, and 30% should be classic on the angiography as determined by a reading center and no more than 3 prior injections of any therapy for the treatment of CNV.
- BCVA for Phase 1: 20/ 80 - count fingers in the study eye; visual acuity in the fellow eye must be the same or better than the study eye
- BCVA for Phase 2: 20/40 to 20/320 in the study eye; visual acuity in the fellow eye must be the same or better than the study eye
- Only one eye of each subject will be treated in the study. If both eyes are eligible, the study eye will be the eye with the worst visual acuity. If visual acuity is the same in both eyes, the eye with the most active CNV will be selected to be the study eye
- Clear ocular media and adequate pupillary dilation in the study eye to permit fundus photography for screening
- Intraocular pressure of 21 mm Hg or less in the study eye.
General Inclusion Criteria
- Subjects of either gender, > 50 years of age
- Subjects who are informed of, and willing and able to comply with, the investigational nature of the study and are able to provide written informed consent
- Ability to return for all study visits
- Females must be of non-child bearing potential (surgically sterilized or at least 2 years post-menopausal) or if of child-bearing potential, the subject must have a negative serum pregnancy test within 14 days prior to the first injection and agree to use 2 forms of effective contraception during the trial and for at least 60 days following the last study injection.
Ocular Exclusion Criteria:
- Any retinal vascular disease or retinal degeneration other than AMD in the study eye
- Serous pigment epithelial detachment without the presence of choroidal neovascularization in the study eye
- Pigment epithelial tears or rips in the study eye
- Previous posterior vitrectomy or retinal surgery in the study eye
- Any periocular infection in the past 4 weeks in the study eye
- During the duration of the study, subjects cannot be on any concomitant therapy with anti-VEGF agents, e.g., Lucentis® , Avastin®, or Macugen® in the study eye (unless identified as rescue therapy given according to protocol guidelines)
- Concomitant therapy or use within 30 days of Baseline (Day 1) of systemic (e.g. intravenous, oral, intramuscular, rectal) corticosteroids in doses > 10 mg/ day prednisone or prednisone equivalent, or use of intravitreous or periocular steroids within 90 days of Baseline (Day 1) in the study eye
- Any current or prior use of extended-release steroid implants (e.g., Retisert®, Posurdex®, Medidur®) in the study eye
- Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of toxicity, or fundus photography.
- Cataract surgery in the study eye within three months of screening
- Trabeculectomy or outflow-device glaucoma surgery in the study eye
- Intraocular surgery in the study eye within three months of screening
- Periocular or ocular infection in the study eye
- Severe myopia (spherical equivalent -8 diopters or greater) in the study eye
- History of vascular pigment epithelial detachment or submacular hemorrhage in the fellow eye.
General Exclusion Criteria:
- Use of any investigational agent or participation in any clinical trial of an investigational agent or investigational therapy that has the potential to affect the disease process (neovascular AMD) in the study eye within sixty (60) days of Baseline (Day 1), or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of Baseline (Day 1). Participation in clinical trials of oral supplements of vitamins and minerals for the prevention of neovascular AMD (e.g. AREDS2) are allowed, as are studies that do not involve the administration of an investigational agent and/or investigational therapy
- Undiagnosed acute illness first observed during screening or between screening and baseline, or severe concurrent medical conditions that, in the investigator's judgment, represent a safety concern.
- Allergy to or prior significant adverse reaction to fluorescein
- Any major surgical procedure within one month of trial entry
- Blood pressure >160/90 mmHg.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485588
|Rocky Mountain Eye Center, P.C.
|Missoula, Montana, United States, 59801 |
|Retina & Vitreous Center of Southern Oregon, P.C.
|Ashland, Oregon, United States, 97520 |
|Palmetto Retina Center
|West Columbia, South Carolina, United States, 29169 |
|Retina Research Center
|Austin, Texas, United States, 78705 |
|Valley Retina Institute, PA
|McAllen, Texas, United States, 78503 |
Iconic Therapeutics, Inc.
No publications provided
||Iconic Therapeutics, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 1, 2011
||February 4, 2015
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 30, 2015
Wet Macular Degeneration