Efficacy and Safety of Supraciliary Dexamethasone Implantation in Patients with Macular Edema: Preliminary and Comparative Study

doi:10.21203/rs.3.rs-4462347/v1

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Efficacy and Safety of Supraciliary Dexamethasone Implantation in Patients with Macular Edema: Preliminary and Comparative Study

https://doi.org/10.21203/rs.3.rs-4462347/v1

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Purpose

To investigate the efficacy and safety of dexamethasone implantation (DEXI) in the supraciliary (SC) region, a potential new implantation site, compared to intravitreal (IVi) application.

Methods

This retrospective cohort study enrolled 39 eyes of 38 patients with macular edema who received DEXI between January and August 2023. Patients were randomized into SC and IVi treatment groups. All patients were followed up for 3 months after DEXI. The maximum retinal thickness (MRT) and central retinal thickness change (ΔCRT), intraocular pressure (IOP), and visual acuity (VA) were assessed preoperatively and postoperatively.

Results

The SC treatment group showed a significant reduction in MRT at 1st and 3rd month visits (p = 0.0002, p = 0.0002). IVi group showed a significant reduction at all postoperative visits (p = 0.0002, p = 0.0004, p = 0.0003). ΔCRT showed no significant difference between SC and IVi groups at any visit (p > 0.05). No significant IOP changes were observed (p > 0.05). No ocular hypertony or hypotony cases on day one post-SC DEXI. VA improved significantly in the SC group compared to the IVi group in the first week (p = 0.014). Subconjunctival hemorrhage was observed in all patients after IVi. No perioperative or postoperative complications were observed in any patients in either group other than subconjunctival hemorrhage.

Conclusion

SC DEXI appears to be a suitable alternative for managing macular edema. It offers comparable effectiveness to IVi administration with potentially fewer complications. Further larger-scale research is needed to validate its long-term safety and efficacy. Anterior segment optical coherence tomography can demonstrate SC DEXI.

Health sciences/Diseases/Eye diseases/Retinal diseases

Health sciences/Medical research/Outcomes research

Corticosteroids are among the most potent and effective anti-inflammatory drugs. Corticosteroids have been widely utilized in ophthalmology due to their anti-inflammatory and anti-neovascularisation properties to anterior and posterior segment diseases (1, 2). They are used via topical, intraocular, and periocular routes, particularly in posterior segment diseases such as non-infectious uveitis, macular edema following retinal vein occlusions or intraocular surgery, and diabetic macular edema (2, 3).

The supraciliary (anterior suprachoroidal) and suprachoroidal spaces form a continuous potential space. The supraciliary space (SC), an anterior route for aqueous humor outflow, lies between the ciliary body and the sclera and extends posteriorly into the suprachoroidal space after the pars plana (4). Suprachoroidal and intravitreal steroid applications are more effective as they bypass ocular barriers and, due to compartmentalization, result in less impact on surrounding tissues, leading to fewer systemic and local side effects (5–7).

There has been significant interest in suprachoroidal drug delivery methods in ophthalmic treatments in recent years. This approach is being explored as a potential alternative for treating posterior segment diseases. Suprachoroidal injections allow ophthalmic drugs to reach target areas such as the choroid and retina more directly and locally, thereby potentially reducing systemic and ocular side effects (8–11). In this regard, the use of suprachoroidal triamcinolone acetonide (TA) was approved in 2021 by the Food and Drug Administration (12).

To date, no study regarding the SC use of the DEX implant is available in the literature. We aim to compare the effectiveness and safety of DEX implant application via a SC route with its intravitreal (IVi) use, thereby determining whether there is an alternative treatment option, especially in selected cases such as aphakic patients or patients with capsular compromise.

This was a single-center, retrospective cohort study of data collected from patients with various causes of macular edema treated with one or more injections of 0,7 mg of DEX implants (Ozurdex® 0.7 mg, Allergan Inc., Irvine, CA, USA) at the outpatient retina clinic of Bursa Uludag University between January 2023 and August 2023. The local institutional review board of the Bursa Uludag University Medical Faculty approved the study protocol, which adhered to the tenets of the Declaration of Helsinki (2023-16/29). All patients were informed about the procedure, acknowledging the off-label application of the medication, and written informed consent was obtained before the injection. All cases were evaluated at pre-injection, during injection, postoperative day 1, postoperative week 1, first-month, and third-month visits, and findings and measurements were noted.

Patient Eligibility

We included patients aged 18 and above who received intraocular DEX injections for macular edema, had comprehensive medical records, and provided images of anterior segment optical coherence tomography (OCT). Exclusion criteria comprised patients under 18, those with concurrent ocular diseases (e.g., glaucoma, scleritis), recent ocular surgery within 3 months, and intraocular pressure (IOP) exceeding 21 mmHg. We also exclude patients who have received certain treatments recently, such as anti-vascular endothelial growth factor injections in the last month, DEX implant injections in the last 6 months, or other types of injections in the last 6 months (such as IVi, suprachoroidal, or SC, subtenon, or peribulbar TA injections). Patients currently undergoing pan-retinal laser photocoagulation therapy after injection, using a topical antiglaucoma medication, or those who are treatment-naive are also excluded. Additionally, individuals with best-corrected visual acuity (BCVA) less than or equal to 0.1 in the untreated fellow eye are not included. Patients with low-quality (< 20 dB) anterior and posterior segment OCT images were excluded from the study.

Ophthalmic Examinations

Before and after injections, patients in both the control and study groups will be retrospectively evaluated through medical records for comparison of refraction, BCVA via ETDRS chart, IOP measured with applanation tonometry and corrected according to pachymetric measurement, anterior segment biomicroscopic examinations, fundoscopic examinations, and anterior/posterior segment optical coherence tomography (OCT) images.

To demonstrate the placement of the DEX implant in supraciliary space and to confirm its correct positioning, anterior segment OCT images were taken in the EDI mode of the anterior sclera in all cases, targeting the implantation site. Anterior segment OCT images were obtained using the Spectralis (Heidelberg Engineering, Heidelberg, Germany) Anterior Segment Module.

We also utilized the Spectralis system for macular OCT imaging. All OCT images were taken by the same ophthalmologist. Measurements were made in a dimly lit room after pupil dilation. An automatic real-time eye tracker was installed during OCT image acquisitions. Before initiating the recording, careful attention was paid to ensure the patient's correct positioning, head alignment, clarity of the image focus, and scan area alignment. Spectralis was configured to perform volume scans of 30° × 25° dimensions, consisting of 32 lines with 512 A-scans each for macular cube measurements. The initial examination served as the reference, with subsequent follow-up examinations automatically applying the same scan settings and positions for consistency. After the imaging, the ophthalmologist reviewed all measurements to ensure fixation was at the fovea, and measurements with segmentation errors were manually corrected. Low-quality images were also adjusted.

The ETDRS subfield measurements were performed using Spectralis maps, an inbuilt Spectralis software program, which divides the subfields into four quadrants and three different diameters of concentric circles (1-mm, 3-mm, and 6-mm diameter), measuring the average macular thickness in that area as done in similar studies before (13). The highest value in these quadrants was the maximum retinal thickness (MRT). Central retinal thickness changes (ΔCRT) were measured from the central fovea subfield within the inner 1-mm-diameter circle. Then, the ΔCRT value was calculated by subtracting the mathematical values at each postoperative visit from the mathematical value at the preoperative measurement [ΔCRT = [(preoperative CRT) - (postoperative CRT)]].

Surgical Procedure

Supraciliary Injection Technique

After topical anesthesia, the patient's eye is covered with a sterile drape. Then, under an operating microscope, marks are made 3.5 mm from the limbus in the temporal superior oblique quadrant for the right eye and the nasal superior oblique quadrant for the left eye. A 0.2–0.3 ml lidocaine injection is then administered subconjunctivally with a 27-gauge needle at these marks. The area is massaged with a cotton swab to reduce subconjunctival swelling. Next, using forceps to stabilize the eye at the limbus, a DEX implant injector is inserted at a 45-degree angle to the sclera, bevel-up, from the 10 o'clock quadrant, 3.5 mm from the limbus, aiming to keep it parallel to the limbus. The injector is advanced 2–3 mm until its metal part is hidden by the sclera, at which point the implant is injected. Pressure is then applied to the injection site with a sterile sponge (see supplementary material 1).

Intravitreal Injection Technique

After topical anesthesia, the patient's eye is covered with a sterile drape. Then, for the right eye, from the temporal superior oblique quadrant, and for the left eye, the nasal superior oblique quadrant, a mark is made on the sclera 3.5 mm from the limbus under an operating microscope. A 0.2–0.3 ml lidocaine injection is administered in the marked area with a 27-gauge needle subconjunctivally. The area is massaged with a cotton swab to reduce subconjunctival swelling. Then, using forceps to stabilize the eye from the limbus, a DEX injector is advanced through the sclera in a 1–2 mm tunnel at a 45-degree angle to the limbus, bevel-up until it reaches the pars plana and enters the vitreous where the implant is injected. Afterward, pressure is applied to the injection site with a sterile sponge.

Statistical Analysis

The Shapiro‒Wilk test was used to test normality, and continuous variables are expressed as median and range while categorical variables are presented as frequencies. Fisher's exact test was used to compare the distributions of categorical variables. Repeated measures ANOVA and one-way ANOVA were used for comparative statistical analysis. All the statistical tests were two-tailed, with a significance level of 0.05. All the statistical analyses were done using IBM SPSS version 28.0 (IBM Corp., released 2021). IBM SPSS Statistics for MacOS. Armonk, NY). The graphics were generated using GraphPad Prism (version 8; GraphPad Software, Inc.).

Thirty-nine eyes of 38 patients were included in the study. Among them, 23 patients were female and 15 were male. Indications included diabetic macular edema in 22 eyes, BRVO in 4 eyes, CRVO in 3 eyes, uveitis in 7 eyes, and postoperative edema in three eyes. In the SC treatment group, the median age was 58 (31–79) years, while in the IVi group, it was 62 (36–79) years (Table 1).

Table 1

Demographics and clinical characteristics of the patients in each group.
Groups	Supraciliary	Intravitreal
Age	58 (31–79)	62 (36–79)
Lens Status Phakic Pseudophakic	10 9	8 11
Sex F M	10 9	13 6
Indications DME BRVO CRVO UCME PCME	10 1 1 5 2	12 3 2 2 1
Number of patients with capsule-lens compromise	1 (SFIOL)	1 (laser capsulotomy)
BRVO: Branch retinal vein occlusion, CRVO: Central retinal vein occlusion, DME: Diabetic macular edema, F: Female, M: Male, PCME: Pseudophakic cystoid macular edema, SFIOL: Scleral fixated intraocular lens, UCME: Uveitic cystoid macular edema.

When the two groups were compared with each other in terms of macular thickness measurements at each visit, no statistically significant difference in retinal thickness was observed in all visits and all macular subgroups (p > 0.05) (Supplementary material 2). Regarding ΔCRT, there was no statistically significant difference between the two groups at all visits (p-values at the 1st week, 1st month, and 3rd-month visits were respectively; p = 0.17, p = 0.4075, p = 0.9773) (Fig. 1). In the SC treatment group, there was a statistically significant reduction in maximum retinal thickness (MRT) at the 1st and 3rd-month visits, except for the postoperative 1st-week visit when compared to the preoperative visit (respectively; p = 0.0002, p = 0.0002, and p = 0.2517). Similarly, when comparing preoperative MRT with postoperative 1st week, 1st, and 3rd-month visits, there was a statistically significant reduction at all postoperative visits (respectively; p = 0.0002, p = 0.0004, and p = 0.0003) (Fig. 2).

A significant difference was observed between the two groups in the postoperative 1st week (p = 0.014), while there was no significant difference in BCVA between the groups preoperatively (p = 0.639). However, no significant differences were found in BCVA between the postoperative 1st and 3rd months (p = 0.078 and p = 0.745). In the SC treatment group, compared to preoperative BCVA with postoperative 1st week, 1st and 3rd-month. BCVA, postoperative BCVA was higher than preoperative BCVA at 1st month (p = 0.0069), but no significant difference was observed at 1st week and 3rd month compared to the preoperative period (respectively; p = 0.0219 and p = 0.169). In the IVi group, no significant difference was observed between preoperative BCVA and BCVA in the postoperative 1st week, 1st and 3rd month (p = 0.2369, p = 0.1024, p = 0.6968, respectively) (Fig. 3).

There were no significant differences in IOPs between preoperative and postoperative 1st week, 1st and 3rd month (p = 0.250, p = 0.078, p = 0.888, p = 0.260) (Fig. 1). No cases of ocular hypertony or hypotony were observed on the 1st day postoperatively in patients who received SC DEX implants. In the SC treatment group, IOP rose to the mid-thirties in one patient, while in the IVi treatment group, it increased to the forties in one patient and to the mid-twenties in two patients, all of whom responded to topical antiglaucoma treatment.

After SC injection, anterior segment OCT showed the SC implant in all patients (Fig. 4). No suprachoroidal hemorrhage, choroidal detachment, ciliary body detachment, or endophthalmitis were observed among the patients with SC implantation. Similarly, none of the patients with IVi DEX implants exhibit sight-threatening complications such as endophthalmitis and retinal detachment.

Nine patients (%47.3) who received SC DEX implants experienced pain during injections. All patients who underwent SC DEX implants developed subconjunctival hemorrhage. Of these patients, four (%21) had hemorrhage between 0 and 90 degrees on the clock dial, thirteen (%68.4) between 90 and 180 degrees, and two (%10.5) between 180 and 270 degrees.

In the SC treatment group, 4 (21.05%) patients experienced clinically significant macular edema recurrence before three months, requiring additional IVi treatment. In the IVi treatment group, 2 (10%) patients required repeat treatment. Similarly, after three months, the number of patients needing further IVi treatment was 5 (26.32%) in the SC treatment group and 4 (20%) in the IVi treatment group. There was no statistically significant difference between the two treatment groups regarding the number of patients requiring treatment before and after three months (p = 0.318 and p = 0.832, respectively).

The intravitreal DEX implant is innovatively designed to achieve a precise combination of potent effects and extended half-life. This biodegradable implant comprises a copolymer of lactic acid and glycolic acid (PLGA) and utilizes the Novadur® drug delivery technology to enable gradual dissolution within the vitreous gel. Through this sustained-release design, the DEX implant delivers preservative-free potent dexamethasone directly into the vitreous cavity, maintaining therapeutic levels for several months (14–16).

In the context of the safety profile of the DEX implants, the Geneva study observed low rates of ocular hypertension, up to 12.6%. Ocular hypertensive episodes associated with the DEX implant are generally transient, with few patients requiring incisional glaucoma surgery (17, 18). Other serious adverse events, such as retinal tear (one event in the 12-month data of the Geneva study) and endophthalmitis (0 events in the 12-month data), appear rare (17).

Anterior migration or dislocation of the DEX implant is a rare complication, usually seen in vitrectomized eyes, aphakic eyes, eyes with reconstructed iris, or compromised posterior capsule or zonular dehiscence. This complication was notably linked to vitrectomized eyes and compromised posterior capsules, leading to corneal edema in about 81.9% of cases and corneal decompensation in 31.4% (15). New techniques have been proposed to enhance the safety of DEX implantation in these patients. One involves leaving a residual vitreous "pad" inferiorly to facilitate embedding the DEX implant, while another technique involves suturing the implant to the sclera with an absorbable suture intraoperatively (19, 20). The success of these anchoring techniques highlights the need for further research into the adaptability of the DEX implant and ways to prevent anterior migration, particularly in vitrectomized, aphakic, and pseudophakic eyes. Thus, caution is advised when using DEX implants in high-risk eyes, and swift action to reposition or remove the implant is essential to prevent corneal complications (21). In our study, SC implant injection was performed in our cases, and no anterior migration was observed.

SC injection of corticosteroids like triamcinolone acetonide (TA) and DEX appears to have a lower risk of increasing IOP compared to other routes of administration, such as IVi administration. Studies indicate that after SC injection of TA, the concentration of the drug in the posterior segment is 12-fold higher than with IVi injection, while only up to 3% enters the anterior chamber (9, 10). This minimizes steroid exposure to the anterior segment and reduces the risk of IOP elevation and cataract formation (22). In a phase 3 trial of suprachoroidal delivery of TA for noninfectious uveitis, the rate of increased IOP was only 11.5%, which is lower than the 25–43% rates reported with IVi DEX implants for uveitic macular edema. These rates appear lower than those reported with IVi DEX implants for uveitic macular edema (9, 10). Additionally, one study found that after a suprachoroidal injection of TA, IOP increased significantly at one month but returned to baseline by three months (8). Another study in rabbits showed acute IOP elevation after suprachoroidal injection that was volume-dependent (11). An anterior suprachoroidal polyurethane implant containing dexamethasone effectively prevented endotoxin-induced uveitis in rats without causing significant ocular toxicity (23). Although a study in rabbits found that suprachoroidal injection of TA caused volume-dependent acute IOP elevation, the overall risk of corticosteroid-related complications like cataracts seems to be reduced with suprachoroidal delivery compared to other routes.

Our study showed no significant difference in the average IOP between cases treated with SC DEX implant and those treated with IVi DEX implant. However, ocular hypertension developed in one patient in the SC group, compared to two patients with higher levels of ocular hypertension in the IVi group. This difference suggests that the limited steroid exposure to the anterior segment in the SC group might be a factor. Existing studies support the possibility of this theory (8–11). Nonetheless, more randomized, controlled, prospective studies with larger patient groups and longer follow-ups are needed. While SC CS delivery can transiently increase IOP in some cases, the risk appears lower than IVi or periocular routes, likely due to the preferential delivery to the posterior segment and reduced exposure to the anterior chamber. More research is still needed to fully characterize the safety profile.

It is known that IVi DEX implantation can cause cataract formation and that the risk increases with repeated injections (24). It has been reported that 12.4% of eyes treated with IVi DEX implants required cataract surgery during follow-ups (25). One limitation of our study is the short follow-up period; cataract progression in patients who underwent SC DEX implants was not assessed. Therefore, more extensive and longer-term studies are needed. However, there have been reports of patients developing rapidly progressing cataracts after IVi treatment, possibly due to lens capsule trauma during injection or wondering of the implant in the vitreous cavity around the lens capsule (26). Nevertheless, theoretically, such a risk does not exist in patients undergoing SC treatment.

Different substances administered via suprachoroidal injection exhibit varying pharmacokinetic properties, with factors such as viscosity, particle size, and water solubility playing significant roles in these differences. Various biopolymers are biocompatible, effective, and capable of extending the half-life of drugs in the suprachoroidal space (27). There is currently no study in the recent literature concerning the DEX implant.

In the group treated with SC DEX implantation, the effect of the DEX implant was relatively shorter compared to the IVi therapy group, and more patients in the SC treatment group required retreatment, yet it was not statistically significant. This could be related to the increased clearance of aqueous-soluble substances like DEX when injected into the suprachoroidal space (27–30). The highly vascular nature of the choroid and ciliary body might be responsible for the increased clearance (30). Similarly, the IVi DEX implant is less effective in vitrectomized eyes (31).

Clinical trials have demonstrated a strong safety profile for suprachoroidal and SC implants, with no significant injection-related concerns such as suprachoroidal hemorrhage, endophthalmitis, or retinal and/or choroidal detachment, contributing to a smoother treatment process and potentially faster resolution of the condition (27, 32). In our study, these complications were not observed in cases treated with SC treatment. We encountered no vision-threatening complications intraoperatively or postoperatively. However, all cases exhibited subconjunctival hemorrhage. This was observed at a higher rate compared to the subconjunctival hemorrhage rates (5.4%-16.6%) reported after IVi therapy in various studies (33). This may be related to the injection technique and use of microforceps that require more manipulation compared to IVi therapy.

In conclusion, the effectiveness of SC and IVi DEX implant applications was similar in our study, with a few exceptions. Therefore, SC DEX implant application can be considered an alternative treatment option, particularly in cases with causes leading to anterior chamber migration, in young patients with high IOP or potential for its increase, and patients with glaucoma or ocular hypertension. Long-term studies and larger series can confirm the effectiveness and safety profile. A special design and drug application method specific to this area would be more appropriate for drug applications showing SC placement. Additionally, anterior segment OCT can be used to demonstrate SC implant placement.

Prior publication: None

Support: The authors have no sources of funding to declare for this manuscript.

Conflicts of interest: The authors declare no conflicts of interest.

Acknowledgment: None

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Supplementary Material 2.

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Editorial decision: revise
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Efficacy and Safety of Supraciliary Dexamethasone Implantation in Patients with Macular Edema: Preliminary and Comparative Study

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Abstract

Purpose

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Results

Conclusion

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Introduction

Materials and Methods

Patient Eligibility

Ophthalmic Examinations

Surgical Procedure

Supraciliary Injection Technique

Intravitreal Injection Technique

Statistical Analysis

Results

Discussion

Declarations

References

Additional Declarations

Supplementary Files

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