Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
Brief Summary: The study involves the enrollment of patients over 18 years of age with diabetic macular edema(DME). Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups:

1. Laser photocoagulation
2. 1mg intravitreal triamcinolone acetonide injection
3. 4mg intravitreal triamcinolone acetonide injection

For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser).

The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better.

Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.


Options:
A: Arm Label: Dexamethasone 700 μg; Type: EXPERIMENTAL; Interventions: Drug: Dexamethasone | Arm Label: Dexamethasone 350 μg; Type: EXPERIMENTAL; Interventions: Drug: Dexamethasone | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Other: Sham | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Dexamethasone 350 μg, Dexamethasone 700 μg | Intervention Type: OTHER; Name: Sham; Assigned to Arm(s): Sham
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Standard of Care Group | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: 1mg triamcinolone acetonide | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: 4mg triamcinolone acetonide | Intervention Type: PROCEDURE; Name: Standard of Care Group; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: 1mg triamcinolone acetonide; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: 4mg triamcinolone acetonide; Assigned to Arm(s): 3
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: fluocinolone acetonide | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Fluocinolone Acetonide | Arm Label: 3; Type: SHAM_COMPARATOR; Interventions: Procedure: Standard of care laser photocoagulation | Intervention Type: DRUG; Name: fluocinolone acetonide; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Fluocinolone Acetonide; Assigned to Arm(s): 2 | Intervention Type: PROCEDURE; Name: Standard of care laser photocoagulation; Assigned to Arm(s): 3
D: Arm Label: Dexamethasone 700 μg; Type: EXPERIMENTAL; Interventions: Drug: Dexamethasone | Arm Label: Dexamethasone 350 μg; Type: EXPERIMENTAL; Interventions: Drug: Dexamethasone | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Other: Sham | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Dexamethasone 350 μg, Dexamethasone 700 μg | Intervention Type: OTHER; Name: Sham; Assigned to Arm(s): Sham

Answer: B