Localized to only the affected quadrants.

Proliferative Diabetic Retinopathy

Diabetes

Panretinal laser treatment of the retina in patients with proliferative diabetic retinopathy.

Panretinal Photocoagulation

The Department of Ophthalmology, Odense University Hospital

The Individually-Marked Panretinal Laser phoTocoagulation for Proliferative Diabetic Retinopathy Study (TREAT)

The Individually-Marked Panretinal Laser phoTocoagulation for Proliferative Diabetic Retinopathy Study: IMPETUS 2018 - TREAT

Change in the progression of PDR, hence the difference in the need for retreatment between the standard laser treatment group vs. the individualized laser treatment group.

Loss of visual field between the standard laser treatment group vs. the individualized laser treatment group.

Change in dark adaptation between the standard laser treatment group vs. the individualized laser treatment group.

The specificity and sensitivity of OCT-A in detecting progression in PDR

Change in visual acuity between the standard laser treatment group vs. the individualized laser treatment group.

Difference in proportion with the development of vitreous haemorrhage between the standard laser treatment group vs. the individualized laser treatment group.

Need for surgical removal of the vitreous between the standard laser treatment group vs. the individualized laser treatment group.

Change in quality of life between the standard laser treatment group vs. the individualized laser treatment group.

Anna Stage Vergmann

Ph. D. student

Odense University Hospital

University of Southern Denmark

Velux Fonden

2mg intravitreal aflibercept (Eylea) injection at baseline, 1M, 2M, 3M, 4M, and 5M

Diabetic Retinopathy

Six number of injections at baseline, 1M, 2M, 3M, 4M, and 5M

Intravitreal Aflibercept injection

Asan medical center

The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Diabetic Retinopathy

The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Patients With Diabetic Retinopathy

Mean changes (%) of retinal nonperfusion (Ischemic index) from baseline

Number of patients who receive rescue treatment due to PDR and time to rescue treatment due to PDR

Number of patients who receive rescue treatment due to DME and time to rescue treatment due to DME

- Visual acuity parameters: Mean changes of BCVA from baseline at every 3 month visit The proportion of subjects with gaining / losing ≥ 15letters or more in BCVA

- Optical coherence tomography (OCT) parameters: Mean changes of Central Retinal Thickness (CRT) from baseline at every 3 month visit Mean changes of Central Retinal Volume from baseline at every 3 month visit Mean change subfoveal choroidal thickness (SFChT) from baseline at every 3 month visit

- Fluorescein angiography (FA) parameters: Baselinenonperfusion area(Ischemic index) at posterior and peripheral retina Baseline degree of vascular leakage at posterior and peripheral retina

Young Hee Yoon

Professor

Asan Medical Center

Patients were administered 0.5-mg IVR injections monthly for 6 months.

Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study

Baseline Characteristics

Sex: Female, Male

Race (NIH/OMB)

Duration of Diabetes Mellitus(DM) (year)

HbA1c(%)

ETDRS charts present a series of five letters of equal difficulty on each row for a total of 14 lines (70 letters). An ETDRS letter score can be calculated as follows: when 20 or more letters are read correctly at 4.0 m, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m plus 30. If fewer than 20 letters are read correctly at 4.0 m, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 m plus the total number of letters read correctly at 1.0 m in the first six lines.

BCVA (ETDRS letters)

Central retinal thickness (CRT) was measured using optical coherence tomography

CRT (um)

Total microaneurysms (number)

MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month)

Microaneurysm-turnover

Perifoveal non-perfused area (mm^2)

BCVA was performed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at baseline and 6 months. The BCVA compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)

Before the treatment regimen, assessment of BCVA using the ETDRS charts.

BCVA Baseline

After completion of the treatment regimen during 6 months, assessment of BCVA using the ETDRS charts.

BCVA Resulte

The Best Corrected Visual Acuity (BCVA)

CRT was performed using OCT at each visit. The OCT measured at each visit was analyzed statistically. the CMT compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)

Before the treatment regimen, assessment of CRT using the OCT.

CRT Baseline

After the treatment regimen during 6 months, assessment of CRT using the OCT.

CRT Resulte

Central Macular Thickness(CMT)

The number of MAs in individual retinas were evaluated during 6 months using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. Changes in MAs were analyzed statistically. the total number of MAs compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)

The number of MAs in individual retinas were evaluated at first visit using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs.

Total MA Baseline

The number of MAs in individual retinas were evaluated during 6 months using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs.

Total MA Resulte

The Total Number of Microaneurysm

number of new MAs detected/month The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month). The microaneurysm formation rate compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)

The Retmarker software was used for automatic measurement and analysis of MA formation at first visit.

The MA Formation Rate Baseline

The Retmarker software was used for automatic measurement and analysis of MA formation during monthly 6 months

The MA Formation Rate Resulte

The Microaneurysm Formation Rate

Number of MAs that resolved/month The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month). The microaneurysm disappearance rate compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)

The Retmarker software was used for automatic measurement and analysis of MA disappearance at first visit.

The MA Disappearance Rate Baseline

The Retmarker software was used for automatic measurement and analysis of MA disappearance during monthly 6 months.

The MA Disappearance Rate Resulte

The Microaneurysm Disappearance Rate

The microaneurysm formation rate + The microaneurysm disappearance rate The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month). The microaneurysm turnover compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)

The Retmarker software was used for automatic measurement and analysis of MA turnover at first visit.

The Microaneurysm Turnover Baseline

The Retmarker software was used for automatic measurement and analysis of MA turnover during monthly 6 months.

The Microaneurysm Turnover Results

The Microaneurysm Turnover

Using ImageJ software (version 1.52a) by FAG image. The Perifoveal non-perfusion area in FAG compare the degree of improvement or worsening of vision at baseline and 6 months. (value at 6 months minus value at baseline)

The perifoveal non-perfused areas in individual retinas were evaluated at first visit using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs

Perifoveal Non-perfusion Area Baseline

The perifoveal non-perfused areas in individual retinas were evaluated during monthly 6 months using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs

Perifoveal Non-perfusion Area Results

Perifoveal Non-perfusion Area in FAG (mm²)

Systemic adverse events (MI, CVA, etc), Ocular adverse events (retinal detachment, RPE tear, endophthalmitis, uveitis, vitreous hemorrhage, subretinal hemorrhage, cataract , IOP elevation, etc) at baseline and each visit.

Complications and adverse events on patients were evaluated.

Safety Parameters Results

Safety Parameters

25 eyes of 25 type 2 diabetes mellitus patients with macular edema were included between August 2016 and February 2019. For 6 months, patients were administered 0.5-mg intra-vitreal Lucentis(Ranibizumab) injections monthly.

Lucentis(Ranivizumab)

Overall Study

Dr. Seung Joon Lee

Systemic adverse events (MI, CVA, etc), Ocular adverse events (retinal detachment, RPE tear, endophthalmitis, uveitis, vitreous hemorrhage, subretinal hemorrhage, cataract , IOP elevation, etc) on patients were evaluated.

Adverse Event

Nonproliferative Diabetic Retinopathy

Local anesthesia with T-caine with Saline irrigation. Routine eye drap was done by potadine-cotton ball. Lucentis injected to vitreous cavity, finally dressing.

Lucentis

Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy

Prospective, Single-center, Six-month Study of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy: Effects on Microaneurysm Turnover and Non-perfused Retinal Area

Yun-Sik Yang

MD, PhD

Wonkwang University Hospital

Novartis Korea Ltd.

Lucentis injections for the first three months of the study and then per the protocol for the duration of the trial.

Argon Laser treatment at enrollment and then per the protocol for the duration of the study.

Diabetic Macular Edema

Lucentis 0.5 mg monthly for the first three months and then per protocol for the duration of the trial.

Ranibizumab (Lucentis)

Argon laser at entry to trial and then per protocol for the duration of the study.

Argon Laser

Rocky Mountain Retina Consultants

Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Lucentis in the Treatment of Macular Edema - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab Versus Focal Laser Treatment in Subjects With Diabetic Macular Edema

vitreous hemorrhage/hypoxie

The Individually-Marked Panretinal Laser phoTocoagulation for Proliferative Diabetic Retinopathy Study (TREAT)

The Efficacy of Intravitreal Aflibercept Injection in Improvement of Retinal Nonperfusion in Diabetic Retinopathy

Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy

Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

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