A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)
This study has been terminated.
(Management Decisoin)
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01603043
First received: May 18, 2012
Last updated: November 15, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to evaluate the safety and efficacy of 12 monthly IVT injections of 0.400 mcg of AL-78898A, a C3 inhibitor, in slow down the rate of progression from base line, of GA lesion size in patients diagnosed with Geographic Atrophy (GA) associated with Age-Related Macular Degeneration (AMD).
| Condition | Intervention | Phase |
|---|---|---|
|
Geographic Atrophy Related to Age-related Macular Degeneration |
Drug: Al-78898A Drug: Sham Injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Masked, Sham-Controlled, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD) |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Mean GA lesion size change from baseline at Month 12 as measured by fundus autofluorescence (FAF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- effect of repeat IVT doses of AL-78898A on best-corrected visual acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | June 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AL-78898A
Investigational Product
|
Drug: Al-78898A
Intravitreal Injection of AL-78898A
|
|
Sham Comparator: Sham Injection
Sham Comparator
|
Drug: Sham Injection
Sham Injection/Sham Comparator
|
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients of age 55 or older at Screening.
- Ability to provide informed consent and comply with the protocol.
Diagnosis of geographic atrophy (GA) of the macula caused by age-related macular degeneration, confirmed within 14 days prior to randomization by the central reading center using fundus autofluorescence images, as well as the following criteria:
- Total GA area in study eye must be of size 1.25-20 mm2 (0.5 - 8 DA), determined by screening images of fundus autofluorescence photographs.
- GA in the study eye can be completely visualized on the macula centered image (Field 2 - Macula Image).
- GA must be able to be photographed in its entirety and not contiguous with any areas of peripapillary atrophy. Images must include the modified 3- field images as defined by the University of Wisconsin standards.
- BCVA of 20 letters (20/400 Snellen equivalent) or better in the study eye at screening.
- BCVA of 20 letters (20/400 Snellen equivalent) or better in the non study eye at screening without conditions other than AMD that, in the opinion of the investigator, could cause a rapid loss of vision.
Exclusion Criteria:
- Any history or current evidence of exudative ("wet") AMD in study eye including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere in the retina based on fluorescein angiogram per Investigator judgment.
- Retinal disease other than AMD in the study eye; however, benign conditions of the vitreous or peripheral retina are not exclusionary (ie, pavingstone degeneration).
- Any ophthalmologic condition in study eye that reduces the clarity of the media and that, in the opinion of the Investigator interferes with ophthalmologic examination (eg, advanced cataract or corneal abnormalities).
- Any ophthalmologic condition in study eye that prevents adequate imaging of the retina judged by the site or reading center.
- A history or current medical diagnosis of glaucoma or ocular hypertension in study eye
- Any ophthalmic condition in study eye that may require surgery during the study period.
- Any contraindication to intravitreal injection including current ocular or periocular infection in the study eye.
- History of any disease or current use of medication expected to cause systemic or ocular immunosuppression (including RESTASIS® use in the study eye).
- History of uveitis or endophthalmitis in the study eye.
- History of intraocular surgery (including cataract surgery) in the study eye within 90 days prior to dosing.
- History of IVT or periocular injection in the study eye at anytime.
- Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or 5 half-lives of the active (whichever is longer) prior to the start of study treatment.
- History of any medical or psychiatric condition, or substance abuse, that in the Investigator's opinion is likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.
- Women of child bearing potential UNLESS they are using a highly effective method of birth control, postmenopausal, or have had well-documented surgical sterilization procedures (see the Manual of Procedures).
- Known or suspected allergy or hypersensitivity to fluorescein or other injectables.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01603043 History of Changes |
| Other Study ID Numbers: | C-12-020 |
| Study First Received: | May 18, 2012 |
| Last Updated: | November 15, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
AMD GA Geographic Atrophy |
Additional relevant MeSH terms:
|
Macular Degeneration Atrophy Geographic Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013