Clinical trial NCT00901186: Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
Official title: A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Visual Impairment
Keywords: Diabetic Macular Edema
Ranibizumab
Laser Treatment
Visual impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

1. Diabetes mellitus 1 or 2, HbA1c \< 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
2. Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
3. Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
4. Central foveal thickness \>250µm (Optical Coherence Tomography).
5. Diabetes medication stable in the 3 months prior.

Exclusion Criteria:

In the study eye:

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

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Percentage of Participants With Improvement in BCVA
timeFrame: 12 months
measure: Evolution of Mean Change From Baseline in BCVA by Study Visit
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.
timeFrame: 12 months
measure: Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Percentage of CRT Change From Baseline by Study Visit
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Almería
country: Spain
facility: Novartis Investigative Site
state: Andalucía
city: Cadiz
country: Spain
facility: Novartis Investigative Site
state: Andalucía
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Valladolid
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: La Laguna
country: Spain
facility: Novartis Investigative Site
state: Las Palmas de Gran Canaria
city: Pamplona
country: Spain
facility: Novartis Investigative Site
state: Navarra
city: Barakaldo
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: