Phase 2 N=83 Randomized Treatment

Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema

Diabetic Macular Edema · Visual Impairment

Bottom Line

View on ClinicalTrials.gov: NCT00901186 ↗

Enrolled (actual)

Serious AEs

6.1%

Results posted

Jul 2014

Primary outcome: Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) — 9.41; 5.79 letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: RFB002 (Drug); Laser photocoagulation (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)	9.41; 5.79	—
SECONDARY Percentage of Participants With Improvement in BCVA	74.29; 68.42	—
SECONDARY Evolution of Mean Change From Baseline in BCVA by Study Visit	4.56; 1.32; 4.61; 1.89; 6.24; 3.11	—
SECONDARY Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.	54.29; 23.68	—
SECONDARY Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit	-50.18; -21.86; -69.52; -14.21; -80.64; -43.16	—
SECONDARY Percentage of CRT Change From Baseline by Study Visit	-12.06; -3.01; -15.61; -2.20; -18.25; -7.97	—

Summary

This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.

Eligibility Criteria

Inclusion Criteria

Diabetes mellitus 1 or 2, HbA1c 250µm (Optical Coherence Tomography).
Diabetes medication stable in the 3 months prior.

Exclusion Criteria

In the study eye:

Active intraocular inflammation.
Any active infection.
History of uveitis.
Structural damage within 500 microns of the center of the macula.
Neovascularization of the iris.
Uncontrolled glaucoma in either eye (Intraocular Pressure > 24 mmHg).

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00901186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.