Observing retinal changes in patients with macular edema from vein blockage
Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion
This study is testing how well a treatment called ranibizumab works for people with macular edema caused by blocked veins in the eye by looking at changes in their retinal images over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Renmin Hospital of Wuhan University Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04140448 on ClinicalTrials.gov |
What this trial studies
This study observes changes in the ischemic index and vascular leakage index using ultra-wide field fluorescein angiography after treatment with anti-VEGF in patients suffering from macular edema due to retinal vein occlusion. The aim is to evaluate how these changes correlate with the effectiveness of the treatment. Participants will receive ranibizumab and undergo ultra-wide fluorescein angiography to assess their retinal condition over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with recent macular edema due to central or branch retinal vein occlusion.
Not a fit: Patients with other retinal diseases or complications that affect vision may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with macular edema secondary to retinal vein occlusion.
How similar studies have performed: Other studies using ultra-wide field fluorescein angiography have shown promise in assessing retinal conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged 18 years or older 2. Macular edema secondary to CRVO,BRVO or HRVO 3. Duration of RVO not more than 4 months 4. Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) completely resolved (normalization of visual acuity and fundus examination) and who have experienced a recurrence of RVO are also considered naive 5. Patient who agrees to participate in the study and who has given his/her written, informed consent Exclusion Criteria: 1. Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period 2. Active or suspected ocular or periocular infection 3. Active severe intraocular inflammation 4. RVO complicated with neovascularization 5. Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye 6. Patient already included in the study for the treatment of the fellow eye 7. Pregnant or breastfeeding woman 8. Lack of effective contraception for women of childbearing age 9. Patient taking part in an interventional study
Where this trial is running
Wuhan, Hubei
- Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: CZ Chen, PHD — Renmin Hospital of Wuhan University
- Study coordinator: CZ Chen, PHD
- Email: whuchenchzh@163.com
- Phone: +86 13072765173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.