None listed
Conditions
Brief summary
This is an observational research study, meaning no investigational drug will be administered and the study involves only gathering data through standard clinical assessments for Geographic Atrophy condition. This study consists of 2 parts. Part 1 is intended to identify potential participants for a separate study and will evaluate changes in Geographic Atrophy characteristics based on optical coherence tomography (OCT) and fundus autofluorescence (FAF) imaging. Part 2 will study the natural disease progression in participants diagnosed with Geographic Atrophy over an up to 18-month period.
Interventions
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by atrophy of retinal tissues and typically occurs in individuals over the age of 50 years. In GA, the buildup of protein and lipid aggregates known as drusen leads to the progressive loss of photoreceptors (PR) and retinal pigment epithelium (RPE) in the macula. Progressive PR degeneration, formation of atrophic lesions, and ultimately vision loss are key phenotypes of GA.
This is a 2-part multi
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by atrophy of retinal tissues and typically occurs in individuals over the age of 50 years. In GA, the buildup of protein and lipid aggregates known as drusen leads to the progressive loss of photoreceptors (PR) and retinal pigment epithelium (RPE) in the macula. Progressive PR degeneration, formation of atrophic lesions, and ultimately vision loss are key phenotypes of GA. This is a 2-part multicenter observational study to assess ocular images collected from participants diagnosed with GA secondary to AMD. The duration of observation is 6 months (Part 1) or 18 months (Part 2). No treatment or experimental intervention will be given in this study. In both Part 1 and Part 2, longitudinal GA progression will be evaluated. In Part 1, data will be collected retrospectively from participants’ medical records; additional ocular images and ophthalmic assessments (optical coherence tomography [OCT] and fundus autofluorescence [FAF]) may also be collected through 6 months. If Part 1 participants are confirmed to meet lesion-specific criteria based on these assessments, they will be asked to screen for Part 2, where further ocular images and ophthalmic assessments (OCT, FAF, and best-corrected visual acuity [BCVA]) will be collected through 18 months. Additionally, a blood sample will be obtained to assess adeno-associated virus (AAV) neutralizing antibody (Nab) titers in serum. Part 2 will occur as soon as eligible study participants are identified from Part 1. Ophthalmic assessments will include BCVA (Part 2 only: Months 0, 3, 6, 12, 18; 5-10 minutes per eye), OCT (Part 1: Months 0, 6; Part 2: Months 0, 3, 6, 12, 18; 5-10 minutes per eye), and FAF (Part 1: Months 0, 6; Part 2: Months 0, 3, 6, 12, 18; 5 minutes per eye). One blood sample will be taken in Part 2 (Month 0). The progression of participants’ GA will be observed from these data.
Sponsors
Kriya Therapeutics, Inc
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria Part 1 (per Medical Chart Review): 1. Participant is able and willing to give informed consent to study participation 2. Clinical diagnosis of GA of the macula secondary to AMD Part 2: 1. Participant must be between 55 to 80 years of age (inclusive). 2.. Clinical diagnosis of GA of the macula secondary to AMD. 3. The GA lesion must meet specific study-defined characteristics for PR and RPE area, GA area/size, lesion growth rate, and hyperautofluorescence pattern. The same group of participants will be used for both parts of the study. Part 1 participants who meet lesion-specific inclusion criteria will be asked to screen for Part 2.
Exclusion criteria
General Exclusion Criteria (Both Parts) Ocular Conditions: • Active or history of macular atrophy secondary to a condition other than age-related macular degeneration such as Stargardt disease, cone-rod dystrophy, or toxic maculopathies like hydroxychloroquine maculopathy in either eye. • High myopia (greater than 6 diopters or an axial length greater than 26 mm). • Exudative age-related macular degeneration diagnosis or any history of or active macular neovascularization in either eye and/or retinal angiomatous proliferation associated with age-related macular degeneration or any other cause including any evidence of retinal pigment epithelium rips or evidence of neovascularization. • Aphakia. • History of vitrectomy, retinal detachment, or corneal transplant in either eye. • Small cup to disc ratio (less than 0.1). • Active or history of uveitis. • Any ocular condition that prevents adequate imaging as determined by the site investigator. • Ocular or periocular infection within 3 months of screening or active uncontrolled intraocular inflammation. Prior/Concomitant Therapy: • Intraocular surgery (including lens replacement surgery) within 3 months prior to screening. • History of laser therapy in the macular region. • Use of subconjunctival gentamicin and intracameral vancomycin within 30 days prior to screening. Part 1 Specific Exclusions • Active or history of ocular disease that in the opinion of the investigator compromises or confounds image data analyses, including but not limited to moderate or severe non-proliferative diabetic retinopathy, uveitis, endophthalmitis, other macular disease (clinically significant epiretinal membrane, full thickness macular hole), or uncontrolled glaucoma/ocular hypertension. • Active or history of any ocular condition other than geographic atrophy secondary to age-related macular degeneration that required or will require surgery or medical intervention or, in the opinion of the investigator, could interfere with data interpretation. Part 2 Specific Exclusions Ocular Conditions: • Presence of an active ocular disease that in the opinion of the investigator compromises or confounds visual function and retinal image quality. • Any ocular condition other than geographic atrophy secondary to age-related macular degeneration that may require surgery or medical intervention during the study period or, in the opinion of the investigator, could compromise visual function during the study period. Other Medical Conditions: • Medical, cognitive or psychiatric conditions that, in the opinion of the investigator, make consistent study assessment and follow-up period unlikely. Prior/Concomitant Therapy: • Active or have history of usage of hydroxychloroquine, pentosan polysulfate sodium, and alkyl nitrites. • Intravitreal steroid injection in 6 months prior to screening. Prior/Concurrent Clinical Study Experience: • Prior experience in another interventional clinical study for intraocularly or suprachoroidally administered therapies in either eye within the past 12 months of date of screening. • Prior experience in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo within the past 12 months from the last dosing at date of screening. • Prior exposure to other adeno-associated virus or adenovirus-based gene therapies or complement inhibitors.
Outcome results
None listed