SAFETY and FEASIBILITY of A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT of DEXAMETHASONE for TREATMENT of MACULAR EDEMA ASSOCIATED with RETINAL VEIN OCCLUSION: A PHASE i CLINICAL TRIAL

Renato B. Cunha, Rubens C. Siqueira, André Messias, Ingrid Scott, Silvia Ligorio Fialho, Armando Da Silva Cunha-Junior, Rodrigo Jorge

Research output: Contribution to journalArticle

Abstract

Purpose: To evaluate the safety and feasibility of a 25-gauge biodegradable implant containing 350 mg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion. Methods: Prospective, nonrandomized, open-label, Phase I clinical trial, including 10 patients with decreased vision (best-corrected early treatment diabetic retinopathy study visual acuity of 20/40 or worse) due to macular edema associated with central retinal vein occlusion (n = 4) or branch retinal vein occlusion (n = 6) for more than 4 months. Comprehensive ophthalmic evaluation, including best-corrected visual acuity, spectral domain optical coherence tomography (Spectralis Heidelberg Engineering) for determination of central subfield thickness, full-field electroretinography (ISCEV standard ERG), and fluorescein angiography, was performed at baseline, and 1, 4, 12, and 24 weeks after intravitreal DDS-25 insertion. Results: Mean best-corrected visual acuity was 0.72 ± 0.1 logMAR (20/100) at baseline and improved by 7 early treatment diabetic retinopathy study letters to 0.58 ± 0.08 logMAR (20/80 + 1) at 24 weeks (P = 0.049), with 3 central retinal vein occlusion and 3 branch retinal vein occlusion patients improving between 1 and 4 early treatment diabetic retinopathy study lines. Significant central subfield thickness reduction was observed at 24 weeks compared with baseline (P = 0.011); mean ± standard error (range) central subfield thickness (mm) was 461.2 ± 41.3 (288-701) at baseline, and 439.6 ± 40.4 (259-631), 442.5 ± 44.6 (255-632), 354.6 ± 31.2 (228-537), and 316.5 ± 26.4 (226-441) at 1, 4, 12, and 24 weeks, respectively. No significant changes in electroretinography responses or area of retinal nonperfusion were observed during 24 weeks of follow-up. There was no significant change in mean intraocular pressure at any of the study visits compared with baseline. One patient had mild anterior chamber inflammation (1-5 cells) at one week after DDS-25 insertion. Conclusion: In this Phase I study demonstrating the feasibility of intravitreal DDS-25 insertion for the treatment of decreased vision due to macular edema associated with retinal vein occlusion, no safety concerns were observed. A larger prospective randomized study with longer follow-up is warranted to confirm these findings.

Original languageEnglish (US)
Pages (from-to)50-58
Number of pages9
JournalRetinal Cases and Brief Reports
Volume12
Issue number1
DOIs
StatePublished - Jan 1 2018

Fingerprint

Absorbable Implants
Retinal Vein Occlusion
Macular Edema
Diabetic Retinopathy
Visual Acuity
Electroretinography
Retinal Vein
Therapeutics
Safety
Clinical Trials, Phase I
Fluorescein Angiography
Optical Coherence Tomography
Feasibility Studies
Anterior Chamber
Intraocular Pressure
Dexamethasone
Prospective Studies
Inflammation

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

Cunha, Renato B. ; Siqueira, Rubens C. ; Messias, André ; Scott, Ingrid ; Fialho, Silvia Ligorio ; Da Silva Cunha-Junior, Armando ; Jorge, Rodrigo. / SAFETY and FEASIBILITY of A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT of DEXAMETHASONE for TREATMENT of MACULAR EDEMA ASSOCIATED with RETINAL VEIN OCCLUSION : A PHASE i CLINICAL TRIAL. In: Retinal Cases and Brief Reports. 2018 ; Vol. 12, No. 1. pp. 50-58.
@article{d5c1335960c842a79946f215856d26b3,
title = "SAFETY and FEASIBILITY of A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT of DEXAMETHASONE for TREATMENT of MACULAR EDEMA ASSOCIATED with RETINAL VEIN OCCLUSION: A PHASE i CLINICAL TRIAL",
abstract = "Purpose: To evaluate the safety and feasibility of a 25-gauge biodegradable implant containing 350 mg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion. Methods: Prospective, nonrandomized, open-label, Phase I clinical trial, including 10 patients with decreased vision (best-corrected early treatment diabetic retinopathy study visual acuity of 20/40 or worse) due to macular edema associated with central retinal vein occlusion (n = 4) or branch retinal vein occlusion (n = 6) for more than 4 months. Comprehensive ophthalmic evaluation, including best-corrected visual acuity, spectral domain optical coherence tomography (Spectralis Heidelberg Engineering) for determination of central subfield thickness, full-field electroretinography (ISCEV standard ERG), and fluorescein angiography, was performed at baseline, and 1, 4, 12, and 24 weeks after intravitreal DDS-25 insertion. Results: Mean best-corrected visual acuity was 0.72 ± 0.1 logMAR (20/100) at baseline and improved by 7 early treatment diabetic retinopathy study letters to 0.58 ± 0.08 logMAR (20/80 + 1) at 24 weeks (P = 0.049), with 3 central retinal vein occlusion and 3 branch retinal vein occlusion patients improving between 1 and 4 early treatment diabetic retinopathy study lines. Significant central subfield thickness reduction was observed at 24 weeks compared with baseline (P = 0.011); mean ± standard error (range) central subfield thickness (mm) was 461.2 ± 41.3 (288-701) at baseline, and 439.6 ± 40.4 (259-631), 442.5 ± 44.6 (255-632), 354.6 ± 31.2 (228-537), and 316.5 ± 26.4 (226-441) at 1, 4, 12, and 24 weeks, respectively. No significant changes in electroretinography responses or area of retinal nonperfusion were observed during 24 weeks of follow-up. There was no significant change in mean intraocular pressure at any of the study visits compared with baseline. One patient had mild anterior chamber inflammation (1-5 cells) at one week after DDS-25 insertion. Conclusion: In this Phase I study demonstrating the feasibility of intravitreal DDS-25 insertion for the treatment of decreased vision due to macular edema associated with retinal vein occlusion, no safety concerns were observed. A larger prospective randomized study with longer follow-up is warranted to confirm these findings.",
author = "Cunha, {Renato B.} and Siqueira, {Rubens C.} and Andr{\'e} Messias and Ingrid Scott and Fialho, {Silvia Ligorio} and {Da Silva Cunha-Junior}, Armando and Rodrigo Jorge",
year = "2018",
month = "1",
day = "1",
doi = "10.1097/ICB.0000000000000413",
language = "English (US)",
volume = "12",
pages = "50--58",
journal = "Retinal Cases and Brief Reports",
issn = "1935-1089",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

SAFETY and FEASIBILITY of A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT of DEXAMETHASONE for TREATMENT of MACULAR EDEMA ASSOCIATED with RETINAL VEIN OCCLUSION : A PHASE i CLINICAL TRIAL. / Cunha, Renato B.; Siqueira, Rubens C.; Messias, André; Scott, Ingrid; Fialho, Silvia Ligorio; Da Silva Cunha-Junior, Armando; Jorge, Rodrigo.

In: Retinal Cases and Brief Reports, Vol. 12, No. 1, 01.01.2018, p. 50-58.

Research output: Contribution to journalArticle

TY - JOUR

T1 - SAFETY and FEASIBILITY of A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT of DEXAMETHASONE for TREATMENT of MACULAR EDEMA ASSOCIATED with RETINAL VEIN OCCLUSION

T2 - A PHASE i CLINICAL TRIAL

AU - Cunha, Renato B.

AU - Siqueira, Rubens C.

AU - Messias, André

AU - Scott, Ingrid

AU - Fialho, Silvia Ligorio

AU - Da Silva Cunha-Junior, Armando

AU - Jorge, Rodrigo

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Purpose: To evaluate the safety and feasibility of a 25-gauge biodegradable implant containing 350 mg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion. Methods: Prospective, nonrandomized, open-label, Phase I clinical trial, including 10 patients with decreased vision (best-corrected early treatment diabetic retinopathy study visual acuity of 20/40 or worse) due to macular edema associated with central retinal vein occlusion (n = 4) or branch retinal vein occlusion (n = 6) for more than 4 months. Comprehensive ophthalmic evaluation, including best-corrected visual acuity, spectral domain optical coherence tomography (Spectralis Heidelberg Engineering) for determination of central subfield thickness, full-field electroretinography (ISCEV standard ERG), and fluorescein angiography, was performed at baseline, and 1, 4, 12, and 24 weeks after intravitreal DDS-25 insertion. Results: Mean best-corrected visual acuity was 0.72 ± 0.1 logMAR (20/100) at baseline and improved by 7 early treatment diabetic retinopathy study letters to 0.58 ± 0.08 logMAR (20/80 + 1) at 24 weeks (P = 0.049), with 3 central retinal vein occlusion and 3 branch retinal vein occlusion patients improving between 1 and 4 early treatment diabetic retinopathy study lines. Significant central subfield thickness reduction was observed at 24 weeks compared with baseline (P = 0.011); mean ± standard error (range) central subfield thickness (mm) was 461.2 ± 41.3 (288-701) at baseline, and 439.6 ± 40.4 (259-631), 442.5 ± 44.6 (255-632), 354.6 ± 31.2 (228-537), and 316.5 ± 26.4 (226-441) at 1, 4, 12, and 24 weeks, respectively. No significant changes in electroretinography responses or area of retinal nonperfusion were observed during 24 weeks of follow-up. There was no significant change in mean intraocular pressure at any of the study visits compared with baseline. One patient had mild anterior chamber inflammation (1-5 cells) at one week after DDS-25 insertion. Conclusion: In this Phase I study demonstrating the feasibility of intravitreal DDS-25 insertion for the treatment of decreased vision due to macular edema associated with retinal vein occlusion, no safety concerns were observed. A larger prospective randomized study with longer follow-up is warranted to confirm these findings.

AB - Purpose: To evaluate the safety and feasibility of a 25-gauge biodegradable implant containing 350 mg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion. Methods: Prospective, nonrandomized, open-label, Phase I clinical trial, including 10 patients with decreased vision (best-corrected early treatment diabetic retinopathy study visual acuity of 20/40 or worse) due to macular edema associated with central retinal vein occlusion (n = 4) or branch retinal vein occlusion (n = 6) for more than 4 months. Comprehensive ophthalmic evaluation, including best-corrected visual acuity, spectral domain optical coherence tomography (Spectralis Heidelberg Engineering) for determination of central subfield thickness, full-field electroretinography (ISCEV standard ERG), and fluorescein angiography, was performed at baseline, and 1, 4, 12, and 24 weeks after intravitreal DDS-25 insertion. Results: Mean best-corrected visual acuity was 0.72 ± 0.1 logMAR (20/100) at baseline and improved by 7 early treatment diabetic retinopathy study letters to 0.58 ± 0.08 logMAR (20/80 + 1) at 24 weeks (P = 0.049), with 3 central retinal vein occlusion and 3 branch retinal vein occlusion patients improving between 1 and 4 early treatment diabetic retinopathy study lines. Significant central subfield thickness reduction was observed at 24 weeks compared with baseline (P = 0.011); mean ± standard error (range) central subfield thickness (mm) was 461.2 ± 41.3 (288-701) at baseline, and 439.6 ± 40.4 (259-631), 442.5 ± 44.6 (255-632), 354.6 ± 31.2 (228-537), and 316.5 ± 26.4 (226-441) at 1, 4, 12, and 24 weeks, respectively. No significant changes in electroretinography responses or area of retinal nonperfusion were observed during 24 weeks of follow-up. There was no significant change in mean intraocular pressure at any of the study visits compared with baseline. One patient had mild anterior chamber inflammation (1-5 cells) at one week after DDS-25 insertion. Conclusion: In this Phase I study demonstrating the feasibility of intravitreal DDS-25 insertion for the treatment of decreased vision due to macular edema associated with retinal vein occlusion, no safety concerns were observed. A larger prospective randomized study with longer follow-up is warranted to confirm these findings.

UR - http://www.scopus.com/inward/record.url?scp=85042463325&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85042463325&partnerID=8YFLogxK

U2 - 10.1097/ICB.0000000000000413

DO - 10.1097/ICB.0000000000000413

M3 - Article

C2 - 27632583

AN - SCOPUS:85042463325

VL - 12

SP - 50

EP - 58

JO - Retinal Cases and Brief Reports

JF - Retinal Cases and Brief Reports

SN - 1935-1089

IS - 1

ER -