Phase 3 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Recruiting NCT06305416 Sponsor: Incepta Pharmaceuticals Ltd Condition: Retinal Vein Occlusion and Diabetic Macular Oedema
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Phase 3 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Recruiting

NCT06305416
Recruiting Phase 3

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 18 years or older
  • People who are able to give written consent and follow the study requirements for the full duration of the trial
  • People who have been diagnosed with type 1 or type 2 diabetes, supported by lab results, or current regular use of insulin or oral diabetes medications
  • People who have retinal swelling caused by fluid in the central part of the macula (the central area of the eye used for detailed vision), which may be associated with diabetic eye disease
  • People whose eye scans (OCT) and clinical examination confirm diabetic macular edema in the center of the macula, with a central thickness measurement greater than 300 microns
  • People whose vision in the study eye falls within a specific range — roughly between 20/400 and 20/40 on an eye chart
  • People whose eyes are clear enough and whose pupils can dilate sufficiently to allow eye scans and retinal photography
  • People who are willing and able to attend all scheduled visits and assessments

Who may not be able to join:

  • People who have received an injection into the study eye (such as Bevacizumab or Ranibizumab), verteporfin, or photodynamic therapy within the past 3 months (certain laser treatments outside the central retina may be acceptable — confirm with trial site)
  • People who have had laser treatment to the study eye within the past 1 month
  • People currently taking part in another eye-related clinical trial or investigation
  • People who are pregnant, have tested positive for pregnancy, or pre-menopausal women not using adequate contraception
  • People with significantly high blood pressure (above 160/100 mmHg), a blood sugar reading at or above 12 mmol/L, or a long-term blood sugar marker (HbA1c) at or above 7.5%
  • People whose macular swelling appears to be caused by a structural problem at the back of the eye or a disease of the optic nerve, as identified by examination or eye scan
  • People who have another eye condition in the study eye that may need treatment during the study, or that could cause vision loss (for example, an advanced cataract, uncontrolled glaucoma, eye inflammation, or a previous corneal transplant) — the trial investigator will make this assessment
  • People whose study eye, in the investigator's opinion, has no realistic chance of vision improvement even if the macular swelling resolves (for example, due to scarring or tissue loss at the back of the eye)
  • People with a suspected active infection in or around the eye, or another eye condition that could affect vision or macular swelling during the study
  • People with bleeding inside the eye (vitreous hemorrhage) that blocks the view of the retina
  • People who have had eye surgery — including vitreous surgery, cataract surgery, or a specific laser capsule procedure (YAG capsulotomy) — in the study eye within the past 3 months
  • People whose other (non-study) eye has vision worse than 20/400
  • People with a known allergy or sensitivity to Ranibizumab or any ingredient in the study medication
  • People who have had a stroke or heart attack within the past 3 months
  • Staff employed at the trial site, people directly involved in running the study, their immediate family members, prisoners, or people who are legally institutionalised
  • People currently taking certain medications known to be harmful to the eye's lens, retina, or optic nerve — including deferoxamine, chloroquine, hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, or ethambutol — and these medications would not be permitted during the study either

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 28 July 2026
Phase 3: approximately ~65% 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

Principal Investigator: Dr. Niaz Abdur Rahman, Managing Director, Bangladesh Eye Hospital & Institute

Phone: +880-2-8891688-703

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 3
Sponsor
Incepta Pharmaceuticals Ltd
Registry
ClinicalTrials.gov
Start date
30 March 2024
Est. completion
1 October 2025

Where this trial is recruiting

Bangladesh

Primary endpoints

Changes in Best Corrected Visual Acuity (BCVA) from Baseline; Changes in Central Subfield Thickness (CST) from Baseline

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: 28 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