| A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema Protocol Status: Completed "Click here to view protocol"
A. Study Design
- Randomized, multi-center clinical trial.
B. Objectives
- This pilot study will compare laser treatment as we now use it (called “standard method”) with a similar laser treatment that is milder in intensity, but more extensive in number (called “mild macular grid” method).
C. Major Eligibility Criteria
- Age >=18 years.
- Study eye with best corrected E-ETDRS acuity >19 letters (20/400 or better).
- Definite retinal thickening due to diabetic macular edema based on clinical exam at or within 500 microns of the macular center for which the investigator believes laser photocoagulation is indicated.
- A thickness of 250 microns or more in the central subfield OR a thickness of 300 microns or more in any one of the four subfields directly adjacent to the central subfield on optical coherence tomography (OCT).
D. Treatment Groups
Randomization to one of two treatment groups:
1. Modified ETDRS laser photocoagulation treatment. 2. Mild Macular Grid photocoagulation treatment. For patients with two study eyes, one eye will randomly be assigned to receive one treatment technique and the other eye will receive the other treatment technique. E. Duration of Follow-Up: Three years. F. Efficacy Outcome
Change in retinal thickening from baseline to 1 year (measured on OCT) G. Sample Size: Approximately 200 patients. H. Schedule of Study Visits and Examination Procedures | | | Follow-up Visits (timed from randomization, months) | | | | Phase 1 | Phase 2 | | | Baseline | 3.5 | 8 | 12 | 24 | 36 | | ETDRS refraction and visual acuity OU | X | X | X | X | X | X | | Fundus photos OU | 7Fa | 3Fa | 3Fa | 7Fa | 7Fa | 7Fa | | ETDRS fluorescein angiography OU | X | | | X | | | | OCT OU | X | X | X | X | X | X | | Eye Examb | X | X | X | X | X | X | | Blood pressure | X | | | X | X | X | | HbA1cc | X | | | X | X | X | | BUN, creatinine, microalbumin | X | | | | | | | Fasting lipid profiled | X | | | | | | | a = | post-laser photos (only field 2 stereo) to be done in addition after any laser treatment. | | b = | exam performed according to investigator’s usual routine | | c = | does not need to be repeated if HbA1c, BUN, creatnine, microalbumin result and lab normal values are available from within the prior 3 months (at baseline, can be performed within 3 weeks after randomization) | | d = | performed after overnight fast; does not need to be repeated if LDL and triglyceride results are available in prior 6 months (at baseline, can be performed within 3 weeks after randomization) | |