Eye injection shows promise for diabetic retinopathy
NCT ID NCT03006081
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether aflibercept injections into the eye can improve areas of poor blood flow in the retina of people with diabetic retinopathy. 38 adults with nonproliferative diabetic retinopathy received the treatment. The goal was to see if the drug could reduce the risk of vision-threatening complications like bleeding or swelling.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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38 people
The number who actually took part.
- Started
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Apr 2016
- Finished
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Aug 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A subject must meet the following criteria to be eligible for inclusion in the study: 1. Adults ≥ 18 years with type 1 or 2 diabetes mellitus 2. Patients diagnosed as nonproliferative diabetic retinopathy with retinal nonperfusion (Ischemic index \>20%) Severe nonproliferative diabetic retinopathy - Early proliferative diabetic retinopathy 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide a signed informed consent form Exclusion Criteria: * A subject who meets any of the following criteria will be excluded from the study. 1. Systemic exclusion criteria 1. Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to baseline or anticipated need for hemodialysis, peritoneal dialysis at any time during the study 2. Acute cardiovascular events (acute myocardiac infarction and/or cerebral infarction) within 1 year before Visit 1 3. Blood HbA1c level greater than 12% at Visit 0 2. Ocular exclusion criteria <!-- --> 1. Diabetic macular edema involving the center of the macula (Defined as the area of the center subfield of OCT, Heidelberg Spectralis: ≥305 in women; ≥320 in men) in the study eye 2. Presence of rubeosis (neovascularization of the iris or the angle) in the study eye 3. Any current or history of retinal diseases that affects visual acuity in the study eye 4. Previous treatment of panretinal photocoagulation 5. Previous treatment with anti-VEGF in study eye within 6 months before Visit 1 6. Previous treatment with intraocular or periocular corticosteroids in the study eye within 6 months before Visit 1 7. Previous history of intraocular surgery other than cataract surgery in the study eye 8. Cataract surgery within 3 months before Visit 1 in the study eye 9. Yttrium-aluminium-garnet (YAG) capsulotomy in the study eye within 1 month before Visit 1 10. Aphakia in the study eye 11. Elevated intraocular pressure (≥ 22 mmHg) in spite of using topical IOP lowering agents at Visit 1 or a diagnosis of glaucoma (Visual field defect corresponding to glaucomatous optic neuropathy) in the study eye 12. Presence of a visually significant cataract in the study eye 13. BCVA score \< 34 letters in the fellow eye 14. Hypersensitivity to aflibercept 15. Ocular or periocular infection 16. Active intraocular inflammation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan medical center
Seoul, Seoul, 05505, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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