Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01823965

LLOMD

Details and patient eligibility

About

In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.

Enrollment: 35 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes mellitus (1 or2)
• decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity<69 letters using E.T.D.R.S testing)
• macular edema

Exclusion criteria

• history of severe cardiac disease
• stroke within 12 months
• intraocular inflammation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

ranibizumab

Experimental group

Treatment:

Drug: ranibizumab