Observational studyOphthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde2026
Intravitreal Fluocinolone Acetonide Implant for Diabetic Macular Edema: 2-Year Results from IDEAL, a Prospective German Observational Study.
Observational study in Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
<p>Introduction: The prospective, observational IDEAL study evaluated the effectiveness and safety of the long-acting fluocinolone acetonide (FAc) implant in patients with chronic diabetic macular edema (DME) and examined the influence of various baseline factors on treatment success.
methodsPatients with persistent DME despite prior treatment with available therapies who received FAc implant were included from 35 ophthalmological centers in Germany and monitored for up to 24 months. Demographic and clinical data, including disease duration, previous treatment, best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), and adverse events were recorded at routine visits and analyzed descriptively, also in predefined groups.
resultsOverall, 214 eyes from 185 patients (57% male) with a mean (SD) age of 66.2 (9.7) years were followed up for a mean (SD) of 21.53 (6.49) months. Functional and anatomical improvements occurred rapidly within 1 week after FAc injection and were sustained over 24 months in these previously intensively treated eyes (72.9% laser treatment, 79.9% intravitreal therapy with dexamethasone and/or anti-VEGF inhibitors, 28.9% vitrectomy). Mean BCVA increased from 55.8 (18.4) letters at baseline to 60.9 (19.0) letters at 24 months, with comparable results across subgroups defined by baseline characteristics. Eyes with fewer than two prior dexamethasone injections showed a more pronounced CMT reduction. In a subset with early follow-up, greater CMT reduction at week 1 was strongly associated with greater CMT reduction at month 1. Mean IOP in the total cohort increased from 15.3 ± 3.3 mm Hg to 17.4 ± 4.8 mm Hg within 9 months and returned to 16.7 ± 5.0 by month 24. IOP lowering was required in 35.5% of eyes (topical medication), and 4.6% underwent IOP-lowering surgery.
conclusionThe IDEAL observational study demonstrated a rapid onset of effect and reaffirmed the long-term efficacy and safety of the FAc implant in a large cohort of patients with persistent DME despite extensive prior treatment, thus underlining the high medical need of this treatment option for DME patients insufficiently responding to other therapies. </p>.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.