Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema

Subgroup analysis of the MEAD study

Ozurdex MEAD Study Group

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34.68 Early Treatment Diabetic Retinopathy Study letters (20/200.20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n=261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham(P < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.

Original languageEnglish (US)
Article number150
JournalBMC Ophthalmology
Volume15
Issue number1
DOIs
StatePublished - Oct 30 2015

Fingerprint

Macular Edema
Dexamethasone
Visual Acuity
Safety
Cataract
Therapeutics
Triamcinolone Acetonide
Retreatment
Optical Coherence Tomography
Diabetic Retinopathy
Vascular Endothelial Growth Factor A
Area Under Curve
Lasers

Keywords

  • Corticosteroid
  • Dexamethasone
  • Diabetic retinopathy
  • Drug delivery
  • Implant
  • Macular edema

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema : Subgroup analysis of the MEAD study. / Ozurdex MEAD Study Group.

In: BMC Ophthalmology, Vol. 15, No. 1, 150, 30.10.2015.

Research output: Contribution to journalArticle

@article{e78941dd71eb481ba5b40fff5fcfd25a,
title = "Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study",
abstract = "Background: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34.68 Early Treatment Diabetic Retinopathy Study letters (20/200.20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n=261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 {\%} of DEX 0.7 patients versus 11.1 {\%} of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham(P < 0.001). Cataract-related adverse events were reported in 70.3 {\%} of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.",
keywords = "Corticosteroid, Dexamethasone, Diabetic retinopathy, Drug delivery, Implant, Macular edema",
author = "{Ozurdex MEAD Study Group} and Augustin, {Albert J.} and Kuppermann, {Baruch D.} and Paolo Lanzetta and Anat Loewenstein and Li, {Xiao Yan} and Harry Cui and Yehia Hashad and Whitcup, {Scott M.} and Suel Abujamra and James Acton and Fareed Ali and Andrew Antoszyk and Awh, {Carl C.} and Adiel Barak and Bartz-Schmidt, {Karl Ulrich} and Baumal, {Caroline R.} and Rubens Belfort and Muna Bhende and Boyer, {David S.} and Bridges, {William Z.} and Brown, {David M.} and Trevor Carmichael and Ken Carnevale and Casella, {Antonio M.} and Tom Chang and Daniel Chechik and Chen, {San Ni} and Chong, {Lawrence P.} and Victor Chong and Joel Corwin and Catherine Creuzot-Garcher and Alan Cruess and Mark Daniell and {De Avila}, {Marcos P.} and {De Moraes}, {Haroldo Vieira} and Devenyi, {Robert G.} and Doft, {Bernard H.} and Mark Donaldson and Richard Dreyer and Dean Eliott and Engel, {Harry M.} and Jan Ernest and Essman, {Thomas F.} and Falcone, {Philip M.} and Sharon Fekrat and Ferencz, {Joseph R.} and Ferreira, {Joao L.} and Joao Figueira and Ivan Fiser and Barrett Katz",
year = "2015",
month = "10",
day = "30",
doi = "10.1186/s12886-015-0148-2",
language = "English (US)",
volume = "15",
journal = "BMC Ophthalmology",
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TY - JOUR

T1 - Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema

T2 - Subgroup analysis of the MEAD study

AU - Ozurdex MEAD Study Group

AU - Augustin, Albert J.

AU - Kuppermann, Baruch D.

AU - Lanzetta, Paolo

AU - Loewenstein, Anat

AU - Li, Xiao Yan

AU - Cui, Harry

AU - Hashad, Yehia

AU - Whitcup, Scott M.

AU - Abujamra, Suel

AU - Acton, James

AU - Ali, Fareed

AU - Antoszyk, Andrew

AU - Awh, Carl C.

AU - Barak, Adiel

AU - Bartz-Schmidt, Karl Ulrich

AU - Baumal, Caroline R.

AU - Belfort, Rubens

AU - Bhende, Muna

AU - Boyer, David S.

AU - Bridges, William Z.

AU - Brown, David M.

AU - Carmichael, Trevor

AU - Carnevale, Ken

AU - Casella, Antonio M.

AU - Chang, Tom

AU - Chechik, Daniel

AU - Chen, San Ni

AU - Chong, Lawrence P.

AU - Chong, Victor

AU - Corwin, Joel

AU - Creuzot-Garcher, Catherine

AU - Cruess, Alan

AU - Daniell, Mark

AU - De Avila, Marcos P.

AU - De Moraes, Haroldo Vieira

AU - Devenyi, Robert G.

AU - Doft, Bernard H.

AU - Donaldson, Mark

AU - Dreyer, Richard

AU - Eliott, Dean

AU - Engel, Harry M.

AU - Ernest, Jan

AU - Essman, Thomas F.

AU - Falcone, Philip M.

AU - Fekrat, Sharon

AU - Ferencz, Joseph R.

AU - Ferreira, Joao L.

AU - Figueira, Joao

AU - Fiser, Ivan

AU - Katz, Barrett

PY - 2015/10/30

Y1 - 2015/10/30

N2 - Background: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34.68 Early Treatment Diabetic Retinopathy Study letters (20/200.20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n=261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham(P < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.

AB - Background: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34.68 Early Treatment Diabetic Retinopathy Study letters (20/200.20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n=261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham(P < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.

KW - Corticosteroid

KW - Dexamethasone

KW - Diabetic retinopathy

KW - Drug delivery

KW - Implant

KW - Macular edema

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U2 - 10.1186/s12886-015-0148-2

DO - 10.1186/s12886-015-0148-2

M3 - Article

VL - 15

JO - BMC Ophthalmology

JF - BMC Ophthalmology

SN - 1471-2415

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