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Tests treatment safety and results for Age-Related Macular Degeneration
Official title A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT03178149
What this study is testing
What is ASP7317?
ASP7317 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Age-related macular degeneration (AMD) is an eye disease which causes people to lose their sharp central vision over time. Aging damages the macula, which is in the middle of the retina - the light-sensitive part at the back of the eye.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- General Participant must be willing to take tacrolimus and willing to discontinue any medications that have a known strong interaction with...
- Participant is able and willing to undertake all scheduled visits and assessments up to the week 52 visit.
- Participant who is taking an antidepressant must be on a stable and effective dosage and must be willing to take it reliably for as long as it is...
- Participant must be willing and medically suitable to undergo monitored anesthesia care during the vitrectomy and subretinal injection.
- Participant agrees to conform to local and institutional policies regarding active COVID-19 infections.
You likely can't join if
- General Exclusion Criteria
- Participant has a history of recurrent varicella zoster virus (VZV) infection or a clinical diagnosis of VZV infection within 4 weeks of the baseline...
- Participant has a history of recurrent cytomegalovirus (CMV) infection or a clinical diagnosis of CMV infection within 4 weeks of the baseline visit...
- Participant has a positive tuberculosis (TB) test during the screening period by an interferon gamma release assay (e.g., QuantiFERON) within the 6...
- Participant has a history or suspected active infection of toxoplasmosis or presence of elevated immunoglobulin M (IgM) toxoplasmosis titer within 4...
- Participant has an active infection (ocular or non-ocular) requiring the prolonged or chronic use of antimicrobial or anti-infective agents.
See the full eligibility criteria
Who can join
- General Participant must be willing to take tacrolimus and willing to discontinue any medications that have a known strong interaction with tacrolimus.
- Participant is able and willing to undertake all scheduled visits and assessments up to the week 52 visit.
- Participant who is taking an antidepressant must be on a stable and effective dosage and must be willing to take it reliably for as long as it is required.
- Participant must be willing and medically suitable to undergo monitored anesthesia care during the vitrectomy and subretinal injection.
- Participant agrees to conform to local and institutional policies regarding active COVID-19 infections.
- Participant agrees not to participate in another treatment study until the 52-week visit has been completed.
- Female participant is not pregnant or at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 52 weeks after investigational product (IP) administration.
- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 52 weeks after IP administration.
- Female participant must not donate ova starting at first dose of IP and throughout the study period and for 52 weeks after IP administration.
- Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 52 weeks after IP administration.
- Male participant must not donate sperm during the treatment period and for 52 weeks after IP administration.
- Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 52 weeks after IP administration. Ocular Study Eye (Both...
- Participant has bilateral AMD and geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) in the study eye. GA is defined as sharply demarcated areas of loss of the retinal pigment...
- Participant has no known history of choroidal neovascularization (CNV) (wet AMD) in either eye prior to enrollment in the trial and no evidence of prior or active CNV with optical coherence tomographyangiography (OCT-A)...
- Participant has absence of exudation as assessed by fluorescein angiography (FA) and spectral domain-optical coherence tomography (SD-OCT).
- Participant has sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging.
- Participant is pseudophakic. Ocular Study Eye (Group 1 only)
- For cohort 1, the participant has a BCVA between light perception and \ /= 20/500) and 37 (\</=20/200) ETDRS letters at the screening visit.
- Participant has the total GA area \</=30.5 mm\^2 (\</=12 disc areas [DA]). Ocular Study Eye (Group 2 only)
- Participant has BCVA score between 38 (\>20/200) and 65 (\</=20/50) ETDRS letters during the screening visit.
- Participant has the total GA area of \>/= 2.54 mm\^2 and \ /=1 and \</=8 DA, respectively) and must reside completely within the fundus autofluorescence (FAF) imaging field (Field 2 to 30 degree image centered on the...
- Participant has a difference in mean mesopic sensitivity \</=2 dB between 2 tests at screening. If not \</=2 dB, a third test may be conducted and mean values between the second and third assessments must be \</=2 dB.
What rules you out
- General Exclusion Criteria
- Participant has a history of recurrent varicella zoster virus (VZV) infection or a clinical diagnosis of VZV infection within 4 weeks of the baseline visit or positive anti-VZV immunoglobulin M (IgM). Being positive for...
- Participant has a history of recurrent cytomegalovirus (CMV) infection or a clinical diagnosis of CMV infection within 4 weeks of the baseline visit or positive anti-CMV IgM. Being positive for IgG, indicative of a past...
- Participant has a positive tuberculosis (TB) test during the screening period by an interferon gamma release assay (e.g., QuantiFERON) within the 6 months prior to the screening. If a participant has tested negative for...
- Participant has a history or suspected active infection of toxoplasmosis or presence of elevated immunoglobulin M (IgM) toxoplasmosis titer within 4 weeks of the baseline visit.
- Participant has an active infection (ocular or non-ocular) requiring the prolonged or chronic use of antimicrobial or anti-infective agents.
- Participant has a current malignancy or history of malignancy within the past 5 years, except non-metastatic basal or squamous cell carcinoma or keratoacanthoma or Bowen's disease or carcinoma-in-situ of the cervix that...
- Participant has a history of a solid organ or bone marrow transplant.
- Participant has any condition that would prohibit the use of systemic immunosuppression with tacrolimus.
- Participant is receiving or has received any immunosuppressive therapy (IMT) (other than topical, inhaled or low dose systemic corticosteroid use not exceeding 7.5 mg of prednisone daily [or equivalent]) within 6 weeks...
- Participant has a history of myocardial infarction in previous 12 months and whose disease is either unstable and/or symptomatic (e.g., angina, dyspnea, etc.).
- Participant has electrocardiogram (ECG) results that are clinically significant and could either jeopardize the safety of the participant, impact the participant's ability to comply with study visit schedule or impact...
- Participant has a study day diastolic blood pressure \> 95 mmHg, at either the screening or baseline visit. Study day blood pressure is defined as the average of the second and third readings at a study visit. If the...
- Participant has an estimated glomerular filtration rate (eGFR) of \</= 30 mL/min, calculated by the chronic kidney disease epidemiology collaboration (CKD-EPI) equation.
- Participant has an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma- glutamyltransferase (GGT) and total bilirubin (TBL) \>/= 2 times the upper limit of normal (ULN).
- Participant has severe anemia (hemoglobin \ 54% [male] or hematocrit \> 49% [female]).
- Participant has a hemoglobin A1c \> 8.5%.
- Participant has a clinically significant coagulopathy (i.e., activated partial thromboplastin time [aPTT] \>/= 1.5 times the ULN and/or prothrombin time adjusted for the international normalized ratio [PT-INR] \>/=2.0).
- Participant has serology results indicative of having syphilis, Lyme disease, human immunodeficiency virus infection or active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or...
- Participant has a history of familial adenomatous polyposis or inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis).
- Participant has a history of allergic reaction to mydriatics or fluorescein.
- Participant has a history of gene therapy or cell transplant therapy, including ASP7316, in a prior clinical study.
- Participant has participated in any studies of an investigational drug or procedure (excluding vitamins and minerals for AMD studies) within 12 weeks prior to the screening visit, except as noted in below criterion.
- Participant has participated with the study eye in any trial of a now FDA-approved complement inhibitor and/or has received an FDA approved complement inhibitor injection in the study eye within 24 weeks of the...
- Participant is unwilling to discontinue or avoid any CYP3A4 inducers (e.g., rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, St John's Wort) or participant is unwilling to discontinue or avoid protease...
- Participant has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, opiates, cocaine, phencyclidine and methadone), unless the drug is taken for a documented medical condition and...
- Participant has macular degeneration due to causes other than AMD (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.)
- Participant has developed CNV (wet AMD), also known as exudative AMD in either eye.
- Participant has foveal sparing as determined by the presence of potentially viable photoreceptors, as evidenced by presence of an intact ellipsoid zone (EZ) \</= 250 microns from the foveal center, based on reading...
- Participant has a history of vitrectomy or submacular surgery, or any surgical intervention for AMD. Participants with a history of non-AMD-related surgical interventions (other than vitrectomy and submacular surgery)...
- Participant has prior treatment with photodynamic therapy (e.g., Visudyne®), intraocular external-beam radiation therapy or transpupillary thermotherapy.
- Participant has a history of previous laser photocoagulation for choroidal neovascularization (CNV), diabetic macular edema, retinal vein occlusion and proliferative diabetic retinopathy.
- Participant has an abnormality of vitreoretinal interface (e.g., tractional epiretinal membrane (ERM)), which can interfere with measurement of macular thickness or with the potential for macular structural damage.
- Participant has a history of cystoid macular edema, retinal vascular occlusion, central serous chorioretinopathy, macular hole or retinoschisis in the study eye.
- Participant has peripheral holes or other peripheral retinal lesions that are considered of rhegmatogenous potential (that is, with a risk of causing retinal detachment).
- Participant has active or history of intraocular inflammation such as uveitis, chorioretinitis and optic neuropathy (other than glaucoma).
- Participant has presence of an ocular toxoplasmosis scar.
- Participant has nevus of Ota (oculodermal melanocytosis), a pigmented choroidal lesion showing characteristics associated with high risk of malignancy (e.g., elevated lesion) or a choroidal nevus in the macula.
- Participant has pathologic myopia defined as a spherical equivalent of \> 8.00 diopters or axial length \> 28 mm at the screening visit, or myopic macular degeneration or posterior staphyloma.
- Participant has glaucoma with uncontrolled intraocular pressure (IOP) (defined as IOP \> 30 mmHg despite treatment with anti-glaucoma medication) or is using more than 2 agents to control IOP or a history of...
- Participant has a history of corneal transplantation.
- Participant has monocular vision; no light perception in the fellow eye or anophthalmic in the fellow eye.
- Participant has a contraindication to pupil dilation.
- Participant has any other ocular condition that can interfere with the assessment of imaging data.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Riverside, California, United States
- Fort Myers, Florida, United States
- Pensacola, Florida, United States
- Atlanta, Georgia, United States
- Oak Forest, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Southaven, Mississippi, United States
- New Brunswick, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- McAllen, Texas, United States
- Seattle, Washington, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; Riverside, California, United States; Fort Myers, Florida, United States; Pensacola, Florida, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.