Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema (DME)
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 185
Healthy volunteers: no

Brief summary:
* To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation
* To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12

Detailed description:

Arms:
arm 1: Drug: iCo-007 350 mcg

iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4 arm 2: Drug: iCo-007 700 mcg

iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 arm 3: Drug: iCo-007 350 mcg and Laser

iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation arm 4: Drug: Ranibizumab and iCo-007 350 mcg

Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later

Interventions: intervention 1: iCo-007 350 mcg intervention 2: iCo-007 700 mcg intervention 3: iCo-007 350 mcg and Laser intervention 4: Ranibizumab and iCo-007 350 mcg
Intervention descriptions: intervention 1: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4 intervention 2: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 intervention 3: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation intervention 4: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later

Protocol document: