Clinical trial NCT03999125: Anti-VEGF Therapy Versus Dexamethasone Implant for DME
Official title: Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Clinically Significant Macular Edema Due to Diabetes Mellitus
Lead sponsor: Sudhalkar Eye Hospital
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, multi-arm trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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) Macular ischemia or proliferative Disease Refusal for enrolment

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 2 years
Secondary outcomes:
measure: Central Subfield Thickness
timeFrame: 2 years
measure: Complications
timeFrame: 2 years
measure: Injection Count
timeFrame: 2 years
Other outcomes:
Locations:
city: Bremerhaven
country: Germany
facility: Alphavision Augenzentrum
state: Bremen
Study officials:
References: