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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00656903
Eligibility Criteria:
* INCLUSION CRITERIA:
* The participant must understand and sign the IRB-approved informed consent document for the study.
* The participant must be greater than or equal to 50 years old.
* The participant must be diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 (alpha)m in size.
* The participant must have CNV or associated exudation secondary to AMD as determined by the investigator.
* The participant must have visual acuity of better than 20/400 in the affected eye as measured on an ETDRS chart.
* The participant has retinal photographs and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice.
* Women participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening, must be willing to undergo a urine pregnancy test throughout the study and must practice an adequate method of birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy or tubal ligation).
The participant must be willing and able to comply with the protocol.
EXCLUSION CRITERIA:
* The participant has CNV, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.
* The participant has geographic atrophy or fibrosis under the fovea that prevents visual acuity improvement at the discretion of the investigator.
* The participant has decreased vision due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis, or epiretinal membrane.
* The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
* The participant has decreased vision due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear of the RPE; a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar cuticular drusen), idiopathic parafoveal telangiectasis, or central serous chorioretinopathy.
* The participant has a history of treatment for CNV in the study eye with focal laser photocoagulation (subfoveal, juxtafoveal or extrafoveal), verteporfin/photodynamic therapy, transpupillary thermotherapy, external beam radiation therapy, or other local treatment (such as submacular surgery) that has resulted in significant subfoveal atrophy or fibrosis as determined by the investigator.
* The participant has had previous ranibizumab, bevacizumab or pegaptanib sodium treatments in the study eye less than four weeks prior to enrollment.
* The participant has had prior verteporfin/photodynamic therapy in the fellow eye less than one week prior to enrollment.
* The participant has evidence of ocular toxoplasmosis; external ocular infection, including conjunctivitis; chalazion; significant blepharitis; or aphakia in the study eye.
* The participant has a history of systemic anti-VEGF therapy less than four weeks prior to enrollment.
* The participant has had intraocular surgery (including lens replacement surgery) within six weeks prior to enrollment.
* The participant has a history of (within the last six months), or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).
* The participant has had a prior vitrectomy in the study eye.
* The participant has medical problems that make consistent follow-up over the treatment period unlikely (e.g., stroke, severe MI, end stage malignancy), any contraindications to performing the necessary diagnostic studies (i.e., known allergy to indocyanine green or fluorescein dyes, etc.), or in general is a poor medical risk because of other systemic diseases or active uncontrolled infections.
* The participant has had insertion of a sclera buckle in the study eye.
* The participant has clinical evidence of scleral thinning (defined as an area of blue/grey discoloration of the sclera representing visualization of underlying choroidal tissue through a thinned area of sclera) seen at the time of external eye examination.
* The participant exhibits clinical signs of myopic retinopathy, or has a refraction of \> spherical equivalent 8.00D in their current prescription. Pseudophakic participants may be enrolled in this study if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the participants cataract surgery of either myopic retinopathy or a refraction of \> spherical equivalent 8.00D.
* The participant has a history of a corneal transplant.
* The participant has infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
* The participant is currently undergoing treatment for active ocular infection.
* The participant has a shellfish allergy, iodine allergy or liver disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00656903
Study Brief:
Protocol Section:
NCT00656903