Phase 2 Macular Degeneration Trial, Recruiting NCT06394232 Sponsor: Eyestem Research Pvt. Ltd. Condition: Macular Degeneration
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Phase 2 Macular Degeneration Trial, Recruiting

NCT06394232
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 50 or older at the time of screening.
  • People who have been diagnosed with Geographic Atrophy (a form of advanced age-related macular degeneration that causes areas of the retina to break down).
  • People whose vision in the study eye is 20/200 or worse on a standard eye chart (with the best possible glasses or contact lens correction). Note: specific vision requirements differ slightly between the two phases of the trial (confirm with trial site).
  • People whose other eye has vision that is equal to or better than the study eye.
  • People who are able and willing to attend all scheduled clinic visits and complete all required study procedures.
  • People who the trial doctor considers medically suitable to undergo anaesthesia, a type of eye surgery called vitrectomy, and an injection under the retina.
  • People who the trial doctor considers medically suitable to receive medication that affects the immune system, as required by this trial.
  • People who are willing and able to read and understand the consent form, or have it read to them, and are willing to sign it before any procedures begin.
  • People who test negative for HIV, Hepatitis B, Hepatitis C, and Tuberculosis.
  • People whose affected area of the retina meets specific size and location requirements as assessed by specialised imaging — the damaged area must be within a certain size range, fully visible on imaging, not connected to the area around the optic nerve, and must include the central part of the retina (confirm with trial site for exact measurements).

Who may not be able to join:

  • People who have signs of a "wet" (neovascular) form of age-related macular degeneration in either eye.
  • People whose Geographic Atrophy is caused by a condition other than age-related macular degeneration (for example, Stargardt disease or damage from certain medications).
  • People who have signs of abnormal blood vessel growth in the study eye due to other eye conditions such as uveitis or certain inflammatory eye diseases.
  • People with a high degree of short-sightedness (greater than -6 diopters) or a longer-than-normal eyeball (more than 26 mm).
  • People whose reduced vision in the study eye is caused by something other than Geographic Atrophy, such as a significant cataract, retinal dystrophy, or other conditions.
  • People who have tears or rips in a layer of the retina (the retinal pigment epithelium) in the study eye.
  • People who have had bleeding inside the eye (vitreous haemorrhage) in the study eye.
  • People with a history of severe diabetic eye disease, swelling of the central retina due to diabetes, blocked retinal veins, or other blood vessel problems affecting the retina in the study eye.
  • People who have previously had vitrectomy surgery (a type of eye surgery) in the study eye.
  • People with a history of a detached retina or surgery to treat a detached retina in the study eye.
  • People with a history of a macular hole in the study eye.
  • People who have had eye surgery other than cataract surgery within the past 2 months, or a specific laser eye procedure (YAG laser capsulotomy) within the past 4 weeks, in the study eye.
  • People who have previously had glaucoma drainage surgery in the study eye.
  • People with a history of glaucoma in the study eye.
  • People with other significant eye conditions affecting the retina (other than age-related macular degeneration).
  • People with active inflammation inside the eye, or any history of a condition called uveitis, in either eye.
  • People with a current eye or surrounding area infection in either eye, or who have had such an infection within 2 weeks before the first screening visit.
  • People with a history of a condition called scleromalacia (thinning of the white of the eye) in either eye.
  • People who have previously had radiation treatment directed at the study eye.
  • People who have had a corneal transplant or who have a corneal dystrophy (a hereditary condition affecting the front of the eye).
  • People who have any other eye condition in the study eye that, in the trial doctor's opinion, could increase risk or interfere with the procedure or results.
  • People who have any other disease or health condition that the trial doctor believes could make the investigational treatment unsafe or affect the reliability of results.
  • People who have taken part in another clinical trial within the 6 months before the baseline visit.
  • People with a known serious allergy to fluorescein dye (used in eye imaging), povidone-iodine, or other medications required for the surgical procedure.
  • People who are pregnant, breastfeeding, or capable of becoming pregnant and unwilling to use adequate contraception throughout the trial.
  • People currently taking aspirin, aspirin-containing products, or other blood-thinning medications that cannot be safely stopped at least 7 days before surgery.
  • People with a condition that significantly weakens their immune system, such as severely uncontrolled diabetes or active cancer.
  • People with a condition called optic atrophy (damage to the nerve connecting the eye to the brain).

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +91 7676235515

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Eyestem Research Pvt. Ltd.
Registry
ClinicalTrials.gov
Start date
4 June 2024
Est. completion
1 April 2025

Where this trial is recruiting

🇮🇳 India

Primary endpoints

Fundus Autofluorescence-

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov