Phase 3 Macular Degeneration Trial, Recruiting

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

Who might be able to join this trial:

• People who previously enrolled in and completed one of three related studies (called Ladder, Archway, or Velodrome) without stopping treatment or leaving the study early, or who were in the Velodrome study and either were not selected for randomisation at Week 24 or completed specific arms of that study
• People who are able and willing to attend all scheduled appointments and complete all required assessments
• Women who could become pregnant must agree to either abstain from heterosexual intercourse or use contraception throughout the study

For Sub-study 1, additional criteria that must be met (for the eye being studied):

• A diagnosis of wet age-related macular degeneration (a specific type of eye condition affecting central vision) made within the past 2 years
• Having received at least two injections of anti-VEGF medication (a type of treatment injected into the eye) for this condition within the past 6 months as part of standard care
• The eye must have shown a positive response to those prior injections, meaning the disease appeared less active on imaging and vision was stable or improved
• All subtypes of the wet macular degeneration condition are permitted, as long as the affected area involves the central part of the retina
• The eye must have clear enough media and pupils that dilate enough to allow the central reading centre to analyse required imaging

Who may not be able to join:

General exclusions:

• People who are pregnant, breastfeeding, or planning to become pregnant during the treatment period or within 28 days of the last eye injection, or within 1 year of the last implant procedure
• People with a history of other eye diseases that raise concern about safely using the study treatment, could interfere with study results, or put them at high risk of complications
• People with a history of other illnesses, metabolic conditions, or abnormal lab results that raise concern about safely using the study treatment or could interfere with study results
• People who need to continuously use any medications or treatments that are prohibited under the study rules

For Sub-study 1 — prior eye treatments (in the eye being studied):

• People who have had vitrectomy (surgical removal of the gel inside the eye), surgery beneath the retina, or other surgical treatment for macular degeneration
• People who have had Visudyne (photodynamic) therapy, external radiation to the eye, or transpupillary thermotherapy
• People who have previously had a steroid injection inside the eye
• People who have previously had a device implanted inside the eye
• People who have had any type of laser treatment for macular degeneration

For Sub-study 1 — prior eye treatments (either eye):

• People who received anti-VEGF injections other than ranibizumab within 1 month before enrolment
• People who participated in a clinical trial involving anti-VEGF drugs (other than ranibizumab trials) within the past 6 months

For Sub-study 1 — characteristics of the eye condition (eye being studied):

• People with bleeding under the retina that involves the centre of the fovea (the very centre of vision) and is larger than a specified size
• People with scar tissue or tissue loss directly beneath the fovea

For Sub-study 1 — characteristics of the eye condition (either eye):

• People whose abnormal blood vessel growth is caused by something other than age-related macular degeneration, such as a fungal infection, eye injury, or severe short-sightedness

For Sub-study 1 — other eye conditions (eye being studied):

• People with a tear in the retinal pigment epithelium (a layer at the back of the eye)
• People with another eye condition (such as cataract, glaucoma, diabetic eye disease, or a membrane on the retina) that may need surgery during the study or could affect results
• People with active inflammation inside the eye
• People with a history of bleeding into the gel inside the eye
• People with a history of retinal detachment of a specific type (where a tear allows fluid behind the retina)
• People with a history of specific retinal tears or breaks within 3 months before enrolment
• People with no natural lens in the eye, or with a damaged or absent lens capsule (with a specific exception for those who had a laser capsule procedure after lens implant surgery)
• People with more than 8 diopters of short-sightedness (very high prescription for distance vision), including those who have had refractive or cataract surgery
• People who have had eye surgery (including cataract surgery) within 3 months before enrolment
• People with uncontrolled eye pressure or glaucoma that may require filtering surgery during the study
• People with a history of glaucoma filtering surgery, tube shunts, or minimally invasive glaucoma procedures
• People with a history of corneal transplant
• People with a history of vitrectomy combined with absence of the lens capsule

For Sub-study 1 — other eye conditions (either eye):

• People with a history of uveitis (inflammation inside the eye) of unknown cause or related to an immune condition
• People with an active infection of the conjunctiva, cornea, white of the eye, or inside of the eye

For Sub-study 1 — general health conditions:

• People who are unable to follow the study schedule or procedures
• People with uncontrolled high blood pressure
• People who have had a stroke within the past 3 months
• People with uncontrolled irregular heart rhythm within the past 3 months
• People who have had a heart attack within the past 3 months
• People with other illnesses or lab findings that suggest a condition that makes use of the study treatment or implant unsafe, or that could affect results
• People currently being treated for an active widespread infection
• People using any systemic (whole-body) anti-VEGF medication
• People using oral corticosteroids (steroid tablets) on an ongoing basis
• People with active cancer within the past 12 months
• People who participated in a non-eye-related investigational drug study within the past month (not counting vitamins or minerals)
• People who have used certain chemotherapy-related medications within 30 days or a specified washout period before enrolment
• People with a history of albinism (a condition affecting pigmentation)
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within the specified timeframes after the last injection or implant procedure

For Sub-study 2 (Cohort 1 only) — eye conditions (eye being studied):

• People with any eye condition that may put them at high risk during surgery or treatment
• People who have had eye surgery (including cataract surgery) within 1 month before enrolment
• People who have ever had any medicated eye implant other than the specific implant used in this study
• People with specific retinal tears or breaks within 3 months before enrolment
• People with any eye condition that would require surgery during the study
• People with a condition affecting the tissue in the upper outer part of the eye (such as scarring, thinning, or a growth) that may affect the implant procedure
• People with ongoing eye complications that could affect their safety

For Sub-study 2 (Cohort 1 only) — eye conditions (either eye):

• People with a suspected or active infection in or around the eye
• People with any history of uveitis (inflammation inside the eye)
• People with active eyelid inflammation (blepharitis)

For Sub-study 2 (Cohort 1 only) — general health conditions:

• People with a recent history (within 3 months) of a condition that makes the study treatment or implant unsafe or could affect results
• People with active cancer within the past 12 months, with some exceptions for certain treated skin or cervical cancers and prostate cancer (confirm with trial site)
• People currently being treated for an active widespread infection
• People who have participated in another investigational drug or device study within 6 months before enrolment (unless enrolled in the related main study)
• People who have used certain chemotherapy-related medications within 30 days or a specified washout period

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