Cataract DME - Peri vs. Intraop

Emory University

Status and phase: Withdrawn; Phase 2

Conditions: Cataract; Diabetic Macular Edema

Treatments: Drug: Aflibercept injected intraoperatively; Drug: Aflibercept injected Pre- and Post-operatively

Study type: Interventional

Funder types: Other

Identifiers

NCT03920878

IRB00106475

Details and patient eligibility

About

Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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.

Full description

Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.

Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Aflibercept injected Pre- and Post-operatively

Experimental group

Description:

Pre- and Post-operative time of Aflibercept injections

Treatment:

Drug: Aflibercept injected Pre- and Post-operatively

Aflibercept injected intraoperatively

Active Comparator group

Description:

Intraoperative time of Aflibercept injection

Treatment:

Drug: Aflibercept injected intraoperatively