European Association for the Study of Diabetic Eye Complications

Annual Meeting Rome 26-27th May 2007

Poster Abstract 10

SUSTAINED MODERATE VISUAL LOSS AS A PREDICTIVE ENDPOINT FOR VISION LOSS IN NONPROLIFERATIVE DIABETIC RETINOPATHY. A Girach, RP Danis, MJ Sheetz, LP Aiello, MD Davis, RC Milton, X Zhi, L Vignati for the PKC-DRS2 Study Group.

Purpose: Oral ruboxistaurin (RBX) has been demonstrated to reduce the occurrence of moderate vision loss (MVL: ≥15 ETDRS letter loss) in eyes with advanced nonproliferative diabetic retinopathy (NPDR). In order to determine whether sustained MVL is a more durable measure than single time-point MVL, we compared the occurrence of sustained (for 6 months) MVL and single time-point MVL within 2 yrs in regard to the presence of MVL sustained for 6 months at 3 yrs of study participation(endpoint SMVL).
Methods: The PKC-DRS2 was a prospective, 36-month, multi-center, parallel, placebo (PBO)-controlled, double-masked phase 3 clinical trial. Patients were randomized to receive RBX 32 mg/day (n=345) or PBO (n=340) once-daily orally. Eligible patients had type 1 or 2 diabetes and these 3 ocular characteristics in at least one eye: moderately severe to very severe NPDR, no previous panretinal photocoagulation, and best-corrected visual acuity (VA) score of ≥45 letters (~20/125, 0.16, 6/36 Snellen).
Results: RBX reduced endpoint sustained MVL by 40% (RBX: 5.5%, PBO: 9.1%, p=0.034). Among eyes with MVL at any single time-point visit before year 2, 23.8% had endpoint SMVL at yr 3 (RBX: 16.4%, PBO: 30.8%, p=0.058). However, among eyes with MVL lasting for at least 6 months before yr 2, 65.0% had endpoint SMVL at yr 3 (RBX: 64.0%, PBO: 66.7%, p=0.864).
Conclusion: Sustained MVL (MVL lasting for at least 6 months) is more predictive of subsequent vision loss than single time-point MVL in patients with moderate to severe NPDR. RBX appears to reduce the occurrence of sustained MVL in patients with single time-point MVL.



Poster Abstract 11

INTRAVITREAL APPLICATION OF TRIAMCINOLONE IN THE TREATMENT OF DIABETIC MACULAR EDEMA. J Dusová, G Kyprianou, J Studni, E Rencová, V Korda. Department of Ophthalmology, Charles University Prague, Medical Faculty in Hradec Kralove, Czech Republic.

Purpose: To evaluate over a one year follow-up period, the efficacy of a 4mg intravitreal triamcinolone (IVT) injection in patients with diabetes mellitus (DM) refractory to laser therapy.
Method: The study group: 20 eyes of 20 patients (15 male, 5 female). The mean age was 61.5 years (29-76). The mean duration of DM in years was 14.5 (range 2-28). Twelve patients (60%) were treated with insulin, 8 patients (40%) were treated with oral antidiabetic drugs. In all patients, treatment with IVT injection was initiated 3 months after the last unsuccessful focal laser coagulation for diabetic macular edema (DME). IVT was performed as an outpatient procedure in aseptic conditions. Five days before IVT all patients underwent: biomicroscopic examination, color fundus photography, best-corrected visual acuity (BCVA) using EDTRS optotypes, macular thickness (MT) estimation using optical coherent tomography (OCT) and applanation intraocular pressure measurement. All these examinations were repeated 1, 3, 6, 9 and 12 months after IVT.
Results: BCVA mean was initially 0.17 ± 0.09 (range 0.08-0.4). It improved to 0.30 ± 0.17 (0.08-0.63) after 1 month, to 0.29 ± 0.16 (0.1-0.63) after 3 months and 0.22 ± 0.14 (0.05-0.5) after 12 months. Improvement of vision was significant in all follow-up months (month 1 p=0.001, month 12 p=0.038).
MT decreased from the initial value of 506.2 ± 91.4m (range 389-719) to 238.8 ± 57.2m (159-352) after 1 month, 287 ± 125.6m (121-541) after 3 months and 362.4 ± 92.6m (211-569) after 12 months. The decrease in MT was significant in all follow-up months. In the first month p<0.0005 and in the 12 month p=0.001. The correlation coefficient between BCVA and MT was -0.467.
Conclusion: Intravitreal triamcinolone injection reduces MT and improves BCVA in patients suffering from DME refractory to laser coagulation. The best IVT effect was observed in the first 3 months after application. Within 12 months we noted a decrease in MT in 90% of patients and an improved visual acuity in 55% of patients.


Poster Abstract 12

DIABETIC MACULAR EDEMA TREATED WITH SUBTENON TRIAMCINOLONE ACETONIDE. RHF de Mendonça, OOM Júnior, CG Machado, WY Takahashi. Ophthalmology Department, University of São Paulo, Brazil

Purpose: To evaluate subtenon injection of triamcinolone acetonide (TA) for refractory laser treated diabetic macular edema (DME).
Methods: Prospective study, between June and December 2005, of subtenon injection of TA in refractory laser treated DME patients. One eye of each of 14 type 2 diabetic patients was studied. Ages ranged from 51 to 74 years (mean 61.4 years (SD=7.4), 42.86% male). Patients underwent best-corrected Snellen visual acuity (VA), intraocular (IOP) measurement, slit lamp biomicroscopy, ‘Stratus' OCT and a posterior subtenon injection of 40 mg TA. IOP was measured at months 1 and 2 and VA and OCT at month 3.
Results: No statistically significant difference was observed between pre- and post-treatment measurements of VA (p= 0.210) and macular thickness (p=0.198). No significant correlation was observed between delta of the VA and macular thickness (r = 0,318; p = 0,267). No statistically significant difference in IOP was observed between pre-treatment and months 1 or 2 (p= 0.152).
Conclusions: Macular thickness and VA remained stable after subtenon triamcinolone acetonide injections for refractory DME. Many studies are still required to establish better treatment results.


Poster Abstract 13

INTREAVITREAL BEVACIZUMAB (AVASTIN) INJECTION IN DIABETIC RETINOPATHY WITH DIFFUSE BREAKDOWN OF BLOOD RETINAL BARRIER. R Lattanzio, G Zerbini,* U Introini, G Tremolada, E Bruschi, A Ramoni, F Scotti, M Setaccioli, P Rama. Department of Ophthalmology & *Medicine Section Nutrition-Metabolism, University Hospital San Raffaele, Milano, Italy.

Purpose: To evaluate the short-term anatomic and functional effects after intravitreal injection of Bevacizumab (Avastin; Genentech), in patients affected by a severe and rare form of diabetic retinopathy with diffuse breakdown of blood-retinal barrier and macular edema (diffuse diabetic capillaropathy).
Methods: This is a retrospective study of 4 patients affected by diffuse diabetic capillaropathy who were treated with intravitreal injection of Bevacizumab (1.25ml). The main outcome measurements were: visual acuity (VA), regression of new vessels and breakdown of blood-retinal barrier by fluorescein angiography, reduction of macular thickness at OCT (before, one week and one month after injection).
Results: At one week and one month after injection all patients demonstrated: improvement of VA, complete or partial regression in leakage due to breakdown of blood-retinal barrier and new vessels, reduction of macular thickness. No significant ocular or systemic adverse events were observed.
Conclusions: The number of patients was limited and the follow-up too short to make any treatment recommendations, but the good results suggest further study is needed.


Poster Abstract 14

CHANGES IN THE DIAMETER OF RETINAL VESSELS IN VIVO AFTER TOPICAL APPLICATION OF A PROSTAGLANDIN AGONIST AND A PROSTAGLANDIN SYNTHESIS INHIBITOR. A PILOT STUDY. K Tilma, J Mehlsen, T Bek. Århus University Hospital, Denmark.

Background: Disturbances in retinal perfusion are believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practise.
Methods: Three normal persons and three type 1 diabetic patients below the age of 30 years and with minimal diabetic retinopathy were studied. The persons were prescribed the prostaglandin agonist xalatan or the prostaglandin synthesis inhibitor voltaren for use twice every day for one week. The baseline diameter and the diameter change during isometric exercise (pressure autoregulation) of a retinal arteriole was measured before and at the end of the treatment period using the Retinal Vessel Analyser.
Results: In both normal persons and in patients with diabetic retinopathy xalatan induced a significant contraction (6.6 ±3.6 m, n=3) while voltaren produced a significant dilation (5.7 ±2.3 m, n=3) of the basal diameter of the measured retinal arteriole. The number of observations was too small to evaluate the effect of the treatment on retinal autoregulation.
Conclusions: Topical treatment with compounds interfering with the effect of prostaglandins may affect the diameter of retinal resistance vessels and consequently affect retinal blood flow. A prospective randomised study is being planned to assess intervention on the retinal prostaglandin metabolism can be used to modulate flow disturbances in diabetic retinopathy.


Poster Abstract 15

CORRELATION BETWEEN MICROPERIMETRY, OPTICAL COHERENT TOMOGRAPHY FINDINGS AND BEST-CORRECTED VISUAL ACUITY OF LASER PHOTOCOAGULATION FOR DIABETIC MACULAR OEDEMA. V Korda, J Studnicka, E Rencova, J Dusova, P Rozsival. Dept. of Ophthalmology, Charles University Prague, Medical Faculty in Hradec Kralove, Czech Republic.

Purpose: To compare the changes in macular sensitivity (microperimetry), macular thickness and best-corrected visual acuity (BCVA) in patients with diabetic macular oedema after laser photocoagulation.
Methods: Retrospective review of 8 consecutive patients (11 eyes, 4 males and 4 females), average age 63.5 (44-77) with macular oedema in diabetic retinopathy (8 eyes with focal exudative macular oedema and 3 eyes with diffuse exudative macular oedema). Patients undergoing retinal photocoagulation with argon laser wave length 532 nm, spot 100-200 µm, exposure time 0.1 s, energy 160-420 mW. All included eyes underwent functional and morphologic examination of the macula. Logarithm of the minimum angle of resolution (logMAR) BCVA was evaluated by means of an ETDRS chart. Foveal thickness was measured by Stratus OCT. Lesion-related macular sensitivity and retinal fixation were investigated with an advanced, automatic microperimeter. Main outcome measures were mean retinal sensitivities within the central 6º area. Results were quantified before and 6 months after treatment.
Results: Mean OCT foveal thickness ± SD significantly decreased from 424 ±72 µm (range 292-599) to 340 ±58µm (range 267-640). logMAR BCVA improved in 45.4% (5) eyes, was unchanged in 36.4% (4) eyes and decreased in 18.2% (2) eyes. Mean central 6º retinal sensitivity ±SD decreased after treatment by 91% eyes to -4,85 ±2,64 [(range -3,25-(-8,0 dB)], while improving in one eye to +0.5 dB.
Conclusions: Changes after treatment of macular oedema may be better documented by adding macular sensitivity mapping by microperimetry. Decreased retinal sensitivities are related to the effect of laser photocoagulation, do not correspond with final BCVA and are towards compared with final reduced macular oedema measured by OCT.


Poster Abstract 16

INCIDENCE, PROGRESSION AND RISK FACTORS FOR DIABETIC RETINOPATHY IN A DANISH DIABETES MANAGEMENT PROGRAMME. M Lind,1 A Green,2,3 M Hansen,1 H Beck-Nielsen,4 AK Sjølie.1 Dept. of Ophthalmology, Odense University Hospital, Denmark;1 Dept. of Applied Research and Health Technology Assessment, Odense University Hospital, Denmark;2 Dept. of Clinical Epidemiology, Institute of Public Health, University of Southern Denmark, Odense, Denmark;3 Dept. of Endocrinology, Odense University Hospital, Denmark.4

Purpose: To evaluate the incidence of and risk factors for development and progression of diabetic retinopathy in a clinic-based photographic diabetes management programme.
Methods: Longitudinal observational study including 729 type 1 (T1DM) and 577 type 2 (T2DM) diabetic patients with at least one follow-up examination in the management programme between 1997 and 2001. Retinopathy was evaluated from two 60º retinal photographs.
Results: Of the 378 T1DM patients without retinopathy at baseline, 121 developed some retinopathy, an incidence rate of 129.2 per 1,000 person-years (PY). The respective figure in T2DM was 103.4 per 1,000 PY. The incidence rate of progression of retinopathy from a level of mild, moderate or severe non-proliferative retinopathy at baseline was 176.6 (175.9), 209.8 (217.7), 222.4 (177.2) per 1,000 PY in T1DM and T2DM patients (in brackets), respectively. No statistically significant difference in the incidence rate was observed between T1DM and T2DM patients at any level of retinopathy (p<0.05). Poisson regression showed that duration of diabetes (incidence rate ratio (IRR)=1.04), BMI (IRR=1.09), HbA1c (IRR=1.20) and increased urinary albumin excretion rate (IRR=1.61) was independently associated with development of retinopathy in patients with T1DM. In patients with T2DM, HbA1c (IRR=1.13) was associated with progression of retinopathy.
Conclusions: The incidence rates of retinopathy were comparable to results from recent European studies using similar photographic methods. Risk factors for development and progression of retinopathy over a short follow-up period were similar to known long-term risk indicators. Incidence and progression of retinopathy was similar among patients with T1DM and T2DM.


Poster Abstract 17

DIABETIC RETINOPATHY IN OUTPATIENTS WITH TYPE 2 DIABETES: CLINICAL AND EPIDEMIOLOGICAL FEATURES. P Lazzari. Diabetes Centre, Hospital of Cremona, Italy.

Purpose: To estimate the prevalence of diabetic retinopathy (DR) and associated risk factors in outpatients with type 2 diabetes in a representative area of Northern Italy.
Methods: A sample of 466 consecutive type 2 diabetics (236 M, 230 F, age 64.6 ±8.5 yr) (out of a total of 2850 subjects) was studied. Patients underwent fundus ophthalmoscopic examination through dilated pupils and, when suitable, fluorescein angiography; other clinical and laboratory examination were also performed.
Results: 20% of patients showed DR (17% background, 3% proliferative). Sex distribution, age, body mass index, fibrinogen, triglycerides, total and HDL cholesterol were similar in patients with and without DR; whereas known duration of diabetes, HbA1c and fasting glycaemia were significantly higher in patients with than without DR (respectively p=0.003; p=0.008; p=0.03). DR frequency was significantly higher in hypertensives than normotensives (p=0.00007), as well as in insulin-treated vs. in non insulin-treated patients (p=0.0003).DR frequency was similar in smokers and in non-smokers, and no relation with albuminuria excretion levels was found. The frequency of coronary heart disease and peripheral diabetic neuropathy was similar in patients with and without DR, whereas peripheral artery disease was significantly more frequent in the former than in the latter (p=0.002). Duration of diabetes, glycaemic control, hypertension, insulin therapy and peripheral vascular disease maintained the above observed significant differences also considering the subgroups with background and proliferative DR with respect to patients without DR.
Conclusions: The results confirm the importance of the role of duration of diabetes in the development of DR, and show its association with some potentially modifiable factors (glycaemic control and hypertension), as well as with some indicators of more severe diabetic disease (insulin therapy and other vascular complications).


Poster Abstract 18

PLASMA HAPTOGLOBIN MAY SIGNAL AN INCREASED RISK OF DEVELOPING PROLIFERATIVE DIABETIC RETINOPATHY IN TYPE 1 DIABETES. T Bek, B Honoré, H Vorum. Århus University Hospital, Denmark

Purpose: Screening for diabetic retinopathy is important for preventing visual loss secondary to the disease. An optimisation of the screening intervals requires increased knowledge of individual risk factors for development of vision threatening retinopathy. In addition to known risk factors such as age, diabetes type, duration, blood pressure, and HbA1c it is likely that genetic factors expressed in the proteom may also play a role. We have previously shown a differential expression of different albumin fractions in proliferative diabetic retinopathy, but a detailed analysis of the albumin free fraction of the plasma is lacking.
Methods: Blood samples from 10 type 1 diabetic patients with proliferative diabetic retinopathy and ten matched patients with no retinopathy was analyzed. The samples were centrifuged and the supernatant was depleted for albumin and immunoglobulins. The remaining plasma proteins were separated by high resolution two-dimensional gel electrophoresis (2D-PAGE). The gels were silver stained and protein spots were defined by Melanie II software. The proteins that differed most between the patients with proliferative retinopathy and controls were extracted, trypsin-digested, and identified by mass spectroscopy.
Results: Approximately 650 protein spots were detected on each gel. Among these there was a significant differential expression of haptoglobin in the plasma of patients with proliferative diabetic retinopathy.
Conclusions: There is differential expression of plasma haptoglobin in type 1 diabetes patients without retinopathy and matched patients with proliferative diabetic retinopathy. This is similar to what has previously been found in patients with diabetic nephropathy. Analysis of plasma haptoglobin may perhaps help identifying patients at risk of developing proliferative diabetic retinopathy in type 1 diabetes.


Poster Abstract 19

EXPERIMENTAL MODEL FOR THE SCREENING OF THE DIABETIC RETINOPATHY IN LAZIO REGION. PILOT STUDY. M Varano, M Parravano, M Tedeschi. Fondazione GB Bietti per lo Studio e la Ricerca in Oftalmologia - IRCCS, Rome, Italy.


Purpose: Diabetic retinopathy (DR) screening and treatment represent the medical procedure with the highest Quality Adjusted Life Year (QALY) benefit. Implementation of DR guidelines of care leads to a substantial reduction of vision loss and costs for the management of the disease. The importance of detecting clinically important lesions of retinopathy is to facilitate the timely administration of treatment strategies to prevent vision loss.
Methods: Lazio region with the G.B. Bietti Eye Foundation-IRCCS collaboration promoted a pilot study to assess the effectiveness of an experimental model for the screening of DR in Lazio region. Patients with a diagnosis of diabetes mellitus and with an age > 12 years will be enrolled in the screening program.
Diabetological centres screening activity represent the first level of the program that will be provided using a non-mydriatic fundus camera. Digital images will be transferred on-line to the reading centre located in the G.B. Bietti Eye Foundation-IRCCS and graded. Patients will then be referred to the second level as necessary for full ophthalmological examination and onward for treatment if required within a third level structure.
Results and conclusions: The screening program characteristics will be described in details.


 




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