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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01823965
Enrollment
35
Registered
2013-04-04
Start date
2011-10-31
Completion date
2014-07-31
Last updated
2016-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Brief summary

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.

Interventions

DRUGranibizumab

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of intravitreal injections of ranibizumab1 years

Secondary

MeasureTime frame
best-corrected visual acuity1 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026