A Phase 3 interventional study of Lucentis in Diabetic Macular Edema and Cataract, sponsored by Second Military Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Second Military Medical University · Phase 3, Interventional, and Treatment
The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Second Military Medical University is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery
Exclusion Criteria:
Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.
Patients with history of vitrectomy. Patients with neovascular glaucoma
Lucentis injected 2 weeks before cataract surgery
Drug: Lucentis
Lucentis injected during the course of the surgery by cataract surgeon.
Drug: Lucentis
Lucentis injected 2 weeks after cataract surgery
Drug: Lucentis
Lucentis 0.5 MG Per 0.05 ML Injection
Change in best-corrected visual acuity (BCVA)
BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.
Time frame: 1 month, 3 months , 6 months and 12 months after cataract surgery
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.
Time frame: 24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery
Total number of postoperative injections
Total number of postoperative injections will be calculated
Time frame: 12 months after cataract surgery
percentage of patients with diabetic retinopathy progression
patients with diabetic retinopathy progression will be calculated
Time frame: 12 months after cataract surgery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Second Military Medical University