Clinically Significant Macular Edema Due to Diabetes Mellitus Clinical Trial
Official title:
Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial
We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.
A randomized, partially masked, observational/interventional trial looking at the efficacy
and safety of 2 FDA approved anti-VEGF agents vis-a-vis the dexamethasone implant as primary
therapy for treatment naive diabetic macular edema in phakic as well as pseudophakic
patients.
Patients with treatment naive clinically significant macular edema will be randomized to
receive one of the aforementioned therapies in a 1:1:1 distribution. Primary inclusion
criteria are :
Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300
microns or greater BCVA < or equal to 6/12.
Exclusion Criteria:
Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can
affect visual assessment(except Cataract Grade II or less as per the LOCS III classification)
Refusal for enrolment
A comprehensive ocular and systemic examination will be performed along with fundus
fluorescein angiography, optical coherence tomography and intraocular pressure measurements
with the Goldmann Applanation Tonometer. The BCVA will be recorded using Snellen's chart
Intravitreal injections will be administered using a standardized technique and under strict
asepsis. No postoperative antibiotics will be given.
Patients will be followed on postoperative days 1, 7 and then monthly for 2 years.
At each visit, the BCVA, IOP, ocular exam and OCT scans will be performed at each visit.
Patients will be treated as per the guidelines laid out for the treat and extend study. For
the dexamethasone implant, re-injections will be allowed first 3 months after the first
injection.
Switch therapy is permissible for anti-VEGF agents after 6 months; first to the other
anti-VEGF(for 6 more injections) and then to the dexamethasone implant. Rescue Laser therapy
is as per physician's description.
Primary outcome measure: The BCVA in each group from baseline to final follow-up at 2 years.
Secondary outcome measure: Change in CST from baseline to years, the number of injections
required per group and the complications, if any.
Statistical Analysis will include demographic descriptions, the Shapiro Wilk test to look for
normality of distribution, multiple measures ANOVA test, Fisher's exact test, Chi-Square test
and paired and unpaired t-test wherever appropriate.
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