Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Study of OT-551 Antioxidant Eye Drop in Participants With Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration
Brief Summary: Othera Pharmaceuticals' Othera (OT)-551 antioxidant eye drop has the potential for chronic treatment of the dry form of age-related macular degeneration. This pilot study of up to 10 eye drop tolerant participants with bilateral geographic atrophy is designed to characterize the effect of 0.45% concentration of OT-551 eye drops given 3 times a day on the progression of geographic atrophy area over a two-year period. Participants will have one eye randomized to receive the eye drop and the fellow eye will be observed only.


Options:
A: DISEASE CHARACTERISTICS:

* Healthy male volunteers
* Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry

  * Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer
* Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
* No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* Systolic blood pressure \< 160 mm Hg
* Diastolic blood pressure \< 90 mm Hg
* No history of hemorrhagic stroke

Other:

* No malignancies within the past 5 years except basal cell or squamous cell skin cancer
* No uncontrolled medical illness
* No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
* No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
* Concurrent multivitamins allowed (supplied on study)
* No concurrent anticoagulation therapy (e.g., warfarin)
* Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed

  * Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel
* Concurrent anti-hypertension medication allowed
* No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)
B: Inclusion Criteria:

* Men aged between 18 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as well
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
C: Inclusion Criteria

1. Participant must understand and sign the protocol's informed consent document (if the participant's vision is impaired to the point where it is not possible to read the informed consent document, the informed consent document will be read in its entirety to the participant).
2. Participant must be able to administer the eye drops or have a caretaker administer the eye drops.
3. Participant must have geographic atrophy (GA) present in both eyes compatible with age-related macular degeneration (AMD). GA is defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round-ish patch of RPE partial depigmentation may still be classified as early GA. The GA in each eye must be able to be photographed in their entirety and not contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
4. Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs.
5. Female participants of child bearing potential (those who are not post-menopausal or surgically sterile) may participate if they are not lactating and if they agree to adequate birth control methods.

4.5 Exclusion Criteria

1. Participant is \> 60 years of age (to minimize fundus changes from causes other than AMD).
2. Participant is in another investigational study and actively receiving study therapy.
3. Participant is unable to comply with study procedures or follow-up visits.
4. Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (e.g., diabetic retinopathy, uveitis, etc.).
5. Participant has a chronic requirement (e.g., ≥ four weeks at a time) for ocular medications for diseases, that in the judgment of the examining physician, are vision threatening or may affect the primary outcome (artificial tears are permitted).
6. Participant has evidence of pseudovitelliform macular degeneration that may confound the outcome of the study in either eye.
7. Participant with evidence of vitreo-retinal traction maculopathy that may confound the outcome of the study in either eye.
8. Participant has a history of laser, photodynamic therapy (PDT), intravitreal injection of any agent (e.g., anti-VEGF, triamcinolone, etc.), or any previous treatment for AMD other than AREDS or equivalent supplement formulation in the study eye.
9. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty.
10. Participant has undergone lens removal in the last three months.
11. Participant is on chemotherapy.
12. Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
13. Participant with a history of malignancy that would compromise the 2-year study survival.
14. Participant with a history of ocular Herpes simplex virus.
15. Participant with a history of or demonstration of allergy to benzakonium chloride, a preservative agent used in the eye drop.
D: Inclusion Criteria:

* Men and women between the ages of 50 and 85 years
* Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye

Exclusion Criteria:

* Ocular media not clear enough to allow good fundus photography

Answer: C