Macular Degeneration Trial, Recruiting NCT07434713 Sponsor: Insel Gruppe AG, University Hospital Bern Condition: Macular Degeneration
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Macular Degeneration Trial, Recruiting

NCT07434713
Recruiting Not Applicable

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:

  • You have been diagnosed with a specific type of wet age-related macular degeneration (wet AMD) where abnormal blood vessels have grown under the central part of your retina, with no restriction on how large the affected area is.
  • Your wet AMD is considered active, meaning scans show fluid under or within the retina, and the scarred area makes up less than half of the total affected area.
  • Your vision in the eye being considered is at least a certain minimum level — roughly equivalent to being able to read the 20/320 line on an eye chart (or scoring 23 letters or more on a special vision test), measured at two separate visits.
  • Only one eye will be treated in this trial; if both eyes qualify, the one with worse vision will be chosen, or the doctor will decide if vision is equal in both eyes.

Who may not be able to join:

  • You are unable or unwilling to follow the study schedule and attend all required appointments.
  • You are currently pregnant or breastfeeding.
  • You are a woman who could become pregnant and are not willing or able to use a reliable form of contraception throughout the entire study (this does not apply if you have had a surgical procedure to prevent pregnancy or have been through menopause for more than 2 years).
  • You have any ongoing illness or are receiving treatment for a condition that, in the doctor's opinion, could significantly affect the study results or put you at extra risk.
  • You have had a stroke or heart attack within the 3 months before signing the consent form.
  • Your blood pressure is not well controlled (specifically, the top number is above 160 or the bottom number is above 100 at either of your screening visits).
  • You have a known allergy or sensitivity to the study drug (aflibercept 8mg) or any of its ingredients.
  • You have previously taken or are currently taking any anti-VEGF medicines by mouth, injection into a vein, or any other systemic route (for example, bevacizumab/Avastin®).
  • You are currently taking, or plan to take, certain medicines known to be harmful to the eye, including chloroquine, hydroxychloroquine (Plaquenil®), deferoxamine, phenothiazines, tamoxifen, or ethambutol.
  • You have used steroid medicines (by mouth, injection, or into the eye) for 30 or more days in a row within the 3 months before signing the consent form.
  • You have taken part in another clinical trial and received an experimental drug within the 6 months before signing the consent form.
  • You previously tried to join this same study but did not qualify at that time.

Regarding the eye being considered for treatment:

  • You have an active infection or inflammation in or around the eye at either screening visit (confirm with trial site).
  • You have glaucoma that is not well controlled, with eye pressure of 30 mmHg or higher even with treatment.
  • You have abnormal blood vessel growth on the iris or a type of glaucoma caused by these new blood vessels.
  • The scans needed to assess your retina cannot be taken with enough clarity for the study team to analyse them.
  • You have had eye surgery (including a certain type of laser capsule procedure) within 2 months before signing the consent form, or you expect to need eye surgery within 6 months after signing.
  • You have certain other eye conditions at your screening visits, such as a significant cataract, a missing or artificial lens, a specific condition affecting the lens (pseudoexfoliation), a large bleed in the eye, a detached retina, diabetic eye disease, or abnormal blood vessel growth caused by something other than wet AMD.
  • There is permanent damage in the central area of your retina that, in the doctor's opinion, means your vision is unlikely to improve even with treatment.
  • There is a large bleed (1 disc diameter or more) directly over the central part of your retina at your screening visits.
  • The eye being considered has ever previously been treated with an anti-VEGF injection, a steroid injection into the eye, photodynamic therapy (a light-based treatment), or any other retinal laser treatment.

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 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Florian M Heussen, Dr. med., Dept. of Ophthalmology, University Hospital, Inselspital

Phone: +41 (0)31 664 54 24

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
Not Applicable
Sponsor
Insel Gruppe AG, University Hospital Bern
Registry
ClinicalTrials.gov
Start date
14 July 2025
Est. completion
27 March 2026

Where this trial is recruiting

🇨🇭 Switzerland

Primary endpoints

Fluid dynamics on OCT scans during the early treatment phase of macular degeneration with Aflibercept 8mg.

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: 22 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