Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT02288559
Eligibility Criteria:
Inclusion Criteria:
* Complement Factor I (CFI) profile biomarker-positive result
* Women of child bearing potential and men should remain abstinent or use contraceptive methods
Exclusion Criteria:
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
* Previous subfoveal focal laser photocoagulation in study eye
* Laser photocoagulation in the study eye
* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
* Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
* Previous cell-based intraocular treatment in study eye
* Intraocular surgery in study eye
* Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
* History of corneal transplant in study eye
* GA in either eye due to causes other than AMD
* Proliferative diabetic retinopathy in either eye
* Active or history of neovascular (wet) AMD in either eye
* History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
* Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
* Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle
* Previous expression vector mediated intraocular treatments
* Uncontrolled blood pressure and atrial fibrillation
* Medical conditions associated with clinically significant risk for bleeding-
* Predisposition or history of increased risk for infection
* Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (\>/=) 12 months
* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection
* Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment
* Previous participation in other studies of investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02288559
Study Brief:
Protocol Section:
NCT02288559