Phase 2 Macular Degeneration Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 85 years old who are willing to take part and agree to the study's terms.
• For one part of the trial (Phase A): people whose eye condition is currently managed with anti-inflammatory eye drops, and who have not yet needed steroid injections into the eye.
• For another part of the trial (Phase B): people whose eye condition no longer responds to anti-inflammatory eye drops and who now require steroid injections into the eye to manage their condition.
• People whose cornea (the clear front surface of the eye) measures between 480 and 620 micrometres thick in the eye being studied, as measured by a special scan.
• People diagnosed with cystoid macular edema (fluid-related swelling at the centre of the retina) in the study eye, confirmed by a specific type of eye scan.
• People whose vision in the study eye falls within a certain range (between 20/400 and 20/25, measured with a pinhole test).
• People whose retinal thickness measures above 300 micrometres in the central part of the study eye, as measured by a scan at the screening visit.
• People who have previously responded to steroid eye treatment, meaning the retina thinned by at least 50 micrometres in response to steroid treatment within the past year.
• People whose macular edema has come back in the study eye.
• People who have previously received a specific steroid injection (triamcinolone acetonide) into the study eye, provided the last dose was at least 8 weeks before the screening visit and no serious treatment-related side effects occurred that the investigator believes could worsen or return with the study treatment.
• Women who could potentially become pregnant must have a negative pregnancy test at the start of the study.
• People whose study eye no longer has its natural lens (either removed and not replaced, or replaced with an artificial lens).

Who may not be able to join:

• People who have had kidney failure requiring dialysis within the 6 months before screening.
• People who have used steroids taken by mouth or given through various other routes (such as injection into a joint, the spine, a bursa, or by inhaler or nasal spray) within 1 month before the baseline visit, or who expect to need them at any point during the study.
• People who have taken oral carbonic anhydrase inhibitor tablets (a type of medication sometimes used for eye pressure or other conditions) within 1 month of screening.
• People who have used certain immune-suppressing or immune-modifying medications within 6 months before screening, or who expect to need them during the study.
• People with a known allergy or sensitivity to the study medication or any of its ingredients.
• People with a confirmed history of HIV.
• People who are unable to complete study requirements for any reason, including being unable to read vision test charts or having a language barrier.
• Women who are pregnant, breastfeeding, planning a pregnancy, or who could become pregnant and are not using a reliable method of contraception.
• People who have taken part in another clinical trial involving an investigational drug or device within 30 days before screening.
• People who, in the investigator's judgement, have a condition or situation that could put them at significant risk, affect the study results, or interfere with their ability to participate.
• People for whom dilating the pupils in either eye is medically inadvisable.
• People with any active eye infection (bacterial, viral, parasitic, or fungal) in either eye at the time of screening.
• People with a history of a specific retinal condition called central serous chorioretinopathy in either eye.
• People who have previously experienced a significant rise in eye pressure in response to steroid treatment in either eye, particularly if it resulted in a pressure increase of 10 mmHg or more (reaching at least 25 mmHg), required three or more pressure-lowering medications, or caused lasting changes.
• People who have previously not responded positively to a steroid injection given around or inside the eye in either eye.
• People with a condition in the study eye that the investigator believes would prevent a meaningful improvement in vision, such as significant scarring, tissue loss, or reduced blood supply to the retina.
• People with a condition in the study eye that the investigator believes would prevent the eye from tolerating a contact lens (such as certain eyelid or surface abnormalities).
• People who have used non-steroidal anti-inflammatory eye drops or steroid eye drops in the study eye within 1 month before screening.
• People with another condition in the study eye severe enough to prevent vision improvement even if the swelling is reduced.
• People with advanced glaucoma or significant glaucoma-related damage to the optic nerve or visual field in the study eye.
• People with eye pressure above 25 mmHg in the study eye at screening, if not currently using any pressure-lowering medication.
• People with active growth of new blood vessels on the optic disc or retina of the study eye at screening.
• People with a history of, or currently active, abnormal blood vessel growth under the retina (choroidal neovascularization) in the study eye.
• People with abnormal blood vessel growth on the iris (the coloured part of the eye) in the study eye at screening.
• People with a history of herpes infection in or around the study eye.
• People with cloudiness or other blockages in the study eye at screening that prevent clear examination or photography (such as bleeding in the eye or a cloudy lens).
• People who have had eye surgery (including cataract surgery) or any type of laser treatment in the study eye within 30 days before screening.
• People who have had a surgical procedure called pars plana vitrectomy in the study eye within 3 months before screening.
• People who have received certain anti-VEGF injections (bevacizumab, ranibizumab, or pegaptanib) into the study eye within 3 months before screening.
• People who have been treated with a dexamethasone implant (Ozurdex®) in the study eye within 6 months before screening.
• People who have received other types of intravitreal injections in the study eye not covered by the above, or doses of certain medications above specified limits, within 3 months before screening (confirm with trial site).
• People who have received a steroid depot injection around the study eye within 3 months before screening (outside of surgery).
• People who are unable to comfortably wear a specific type of contact lens for 1 hour during a run-in period before the study begins.
• People with certain structural changes to the cornea of the study eye (called guttae or Descemet's folds).
• People with blood vessel growth that extends 2 mm or more into the cornea of the study eye.
• People whose non-study eye has very poor vision (below a certain threshold on a letter chart) at the screening visit.

Important: Always verify eligibility with the trial site directly before applying.