A Phase 4 interventional study of Bevacizumab and dexamethasone intravitreal implant in Diabetic Macular Edema, sponsored by Maturi, Raj K., M.D., P.C.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-29.
Sponsored by Maturi, Raj K., M.D., P.C. · Phase 4, Interventional, and Treatment
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
Maturi, Raj K., M.D., P.C. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Drug: Bevacizumab
Bevacizumab plus Ozurdex
Drug: Bevacizumab · Drug: dexamethasone intravitreal implant
intravitreal, 1.25mg., monthly
Also known as: Avastin
0.7mg, intravitreal every 4 months
Also known as: Ozurdex
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Time frame: baseline to 12 month
OCT CST
change in optical coherence tomography central subfield thickness
Time frame: change in OCT CST from baseline to twelve months
The study was conducted at a single center. The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)
| Milestone | Bevacizumab Alone | Combined Group |
|---|---|---|
| Started | 19 | 21 |
| Completed | 17 | 18 |
| Not completed | 2 | 3 |
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
| letters | Bevacizumab Alone | Combined Group |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline | 4.9 ± 12.3 | 5.4 ± 10.7 |
change in optical coherence tomography central subfield thickness
| microns | Bevacizumab Alone | Combined Group |
|---|---|---|
| OCT CST | 30 ± 100 | 45 ± 107 |
Collected over 1 year. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab Alone Group | — | 2/9 (22.2%) | 9/9 (100%) |
| Combined Group | — | 8/21 (38.1%) | 21/21 (100%) |
| Event | Bevacizumab Alone Group | Combined Group |
|---|---|---|
| acute renal insufficiencyRenal and urinary disorders | 1/9 | 1/21 |
| cerebrovascular accidentVascular disorders | 1/9 | 0/21 |
| spinal stenosisMusculoskeletal and connective tissue disorders | 1/9 | 0/21 |
| cellulitisInfections and infestations | 0/9 | 1/21 |
| coronary artery diseaseCardiac disorders | 0/9 | 1/21 |
| hyperkalemiaMetabolism and nutrition disorders | 0/9 | 1/21 |
| pancytopeniaBlood and lymphatic system disorders | 0/9 | 1/21 |
| pneumoniaRespiratory, thoracic and mediastinal disorders | 0/9 | 1/21 |
| generalized weaknessGeneral disorders | 0/9 | 1/21 |
| worsening of hypertensionCardiac disorders | 0/9 | 1/21 |
| Event | Bevacizumab Alone Group | Combined Group |
|---|---|---|
| worsening of cataractEye disorders | 7/9 | 8/21 |
| epiretinal membraneEye disorders | 5/9 | 4/21 |
| neovascularization of retinaEye disorders | 3/9 | 1/21 |
| increased intraocular pressureEye disorders | 2/9 | 6/21 |
| posterior capsule opacificationEye disorders | 0/9 | 6/21 |
| loss of blood sugar controlMetabolism and nutrition disorders | 1/9 | 5/21 |
| sinusitisInfections and infestations | 0/9 | 5/21 |
| dizzinessGeneral disorders | 2/9 | 0/21 |
| upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 2/9 | 2/21 |
| vitreous floaterEye disorders | 1/9 | 4/21 |
The unit of "eyes" is used to described the number of participants since some subjects had both eyes in the study and it is not feasible to separate those into their own group.
| Age, Categorical(Participants) | Bevacizumab Alone | Combine Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 14 | 16 | 30 |
| Age, Continuous(years) | Bevacizumab Alone | Combine Group | Total |
|---|---|---|---|
| Mean | 62 ± 9 | 59 ± 12 | 60.5 ± 10 |
| Sex: Female, Male(Participants) | Bevacizumab Alone | Combine Group | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 10 | 11 | 21 |
| Region of Enrollment(eyes) | Bevacizumab Alone | Combine Group | Total |
|---|---|---|---|
| United States | 19 | 21 | 40 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone Intravitreal Implant
Maturi, Raj K., M.D., P.C.