A 12-month, two-armed, randomized, double-masked, multicenter, Phase IIIb study assessing the efficacy and safety of laser photocoagulation as adjunctive to Ranibizumab intravitreal injections vs. laser photocoagulation monotherapy in patients with visual impairment due to diabetic macular edema followed by a 12 month follow up period

Registry ID

EUCTR2010-018852-29

Source registry

EUCTR

Status

Prematurely Ended

Phase

PHASE3

Sponsor

Novartis Pharma GmbH

Start date

2010-06-10

Completion date

2011-05-20

Last update

2026-08-16

Conditions

• diabetic macular edema

Summary

The primary objective of this study is to demonstrate superiority of an adjunctive treatment of laser photocoagulation to Ranibizumab 0.5 mg as intravitreal injection in the mean change in BCVA from baseline to month 12 compared to laser monotherapy.

Locations

• , , Germany

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