Skip to main content
Top
Published in: BMC Ophthalmology 1/2020

01-12-2020 | Vitrectomy | Research article

Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial

Authors: Ahmed Hosni Abd Elhamid, Ahmed Abd El Alim Mohamed, Abeer Mohamed Khattab

Published in: BMC Ophthalmology | Issue 1/2020

Login to get access

Abstract

Background

To compare efficacy and safety of intravitreal aflibercept (IVA) injection with panretinal photocoagulation (PRP) versus early vitrectomy for diabetic vitreous hemorrhage (VH).

Methods

Prospective, randomized study that included 34 eyes with diabetic VH. They were divided into two groups, Group Ι (17 eyes) received three successive IVA injections followed by PRP and group ΙΙ (17 eyes) for whom early vitrectomy was done. Follow up was carried out after one, two, three, six and nine months. The primary outcome measure was change in the mean best corrected visual acuity (BCVA) after nine months, secondary outcome measures were mean duration of clearance of VH and rate of recurrent hemorrhage with any additional treatment in both groups. Complications were reported.

Results

There was no statistically significant difference regarding initial demographic criteria between both groups. The mean final log MAR BCVA was statistically better than the initial BCVA in both groups (0.51 ± 0.20, 1.17 ± 0.48 for group I and 0.48 ± 0.18, 1.44 ± 0.44 for group II, P < 0.001). There was no statistically significant difference between both groups regarding the mean final Log Mar BCVA (0.51 ± 0.20 for group I, 0.48 ± 0.18 for group II, p ≥ 0.05), the mean duration of clearance of VH was 7.8 ± 1.8 weeks, 5 days for group I and II respectively. PRP was completely done for all eyes in group I after three months. The difference in the recurrence rate between group I (29.4%) and group II (11.8%) was statistically significant (p < 0.05). Vitrectomy was done for three eyes (17.6%) due to recurrent non-resolving VH in group I. late recurrent VH occurred in two eyes (11.8%) in group II, IVA was given with complete clearance of the hemorrhage. No vision threatening complications were reported in both groups.

Conclusion

Both intravitreal injection of aflibercept followed by PRP and early vitrectomy are effective and safe modalities for treatment of diabetic vitreous hemorrhage. Early vitrectomy leads to faster vision gain with less incidence of recurrence than intravitreal injection.

Trial registration

Randomized clinical trial under the number of NCT04153253 on November 6, 2019 “Retrospectively registered”.
Literature
1.
go back to reference Michels RG. Proliferative diabetic retinopathy: pathophysiology of extra retinal complications and principles of vitreous surgery. Retina. 1981;1:1–17.PubMed Michels RG. Proliferative diabetic retinopathy: pathophysiology of extra retinal complications and principles of vitreous surgery. Retina. 1981;1:1–17.PubMed
2.
go back to reference Sinawat S, Rattanapakorn T, Sanguansak T, Yospaiboon Y. Intravitreal bevacizumab for proliferative diabetic retinopathy with new dense vitreous hemorrhage after full panretinal photocoagulation. Eye. 2013;27:1391–6.CrossRef Sinawat S, Rattanapakorn T, Sanguansak T, Yospaiboon Y. Intravitreal bevacizumab for proliferative diabetic retinopathy with new dense vitreous hemorrhage after full panretinal photocoagulation. Eye. 2013;27:1391–6.CrossRef
3.
go back to reference Simunovic MP, Maberley DA. Anti-vascular endothelial growth factor therapy for proliferative diabetic retinopathy: a systematic review and meta-analysis. Retina. 2015;35:1931–42.CrossRef Simunovic MP, Maberley DA. Anti-vascular endothelial growth factor therapy for proliferative diabetic retinopathy: a systematic review and meta-analysis. Retina. 2015;35:1931–42.CrossRef
4.
go back to reference Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL III, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015;314:2137–46.CrossRef Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL III, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015;314:2137–46.CrossRef
5.
go back to reference Bshavsar AR, Torres K, Glassman RA, et al. Evaluation of results 1 year following short-term use of ranibizumab for vitreous hemorrhage due to proliferative diabetic retinopathy. JAMA Ophthalmol. 2014;132(7):889–90.CrossRef Bshavsar AR, Torres K, Glassman RA, et al. Evaluation of results 1 year following short-term use of ranibizumab for vitreous hemorrhage due to proliferative diabetic retinopathy. JAMA Ophthalmol. 2014;132(7):889–90.CrossRef
6.
go back to reference Parikh RN, Traband A, Kolomeyer AM, VanderBeek BL, Kim BJ, Maguire AM, Brucker AJ. Intravitreal bevacizumab for the treatment of vitreous hemorrhage due to proliferative diabetic retinopathy. Am J Ophthalmol. 2017;176:194–202.CrossRef Parikh RN, Traband A, Kolomeyer AM, VanderBeek BL, Kim BJ, Maguire AM, Brucker AJ. Intravitreal bevacizumab for the treatment of vitreous hemorrhage due to proliferative diabetic retinopathy. Am J Ophthalmol. 2017;176:194–202.CrossRef
7.
go back to reference Khuthaila MK, Hsu J, Chiang A, et al. Postoperative vitreous hemorrhage after diabetic 23-gauge pars plana vitrectomy. Am J Ophthalmol. 2013;15:757–63.CrossRef Khuthaila MK, Hsu J, Chiang A, et al. Postoperative vitreous hemorrhage after diabetic 23-gauge pars plana vitrectomy. Am J Ophthalmol. 2013;15:757–63.CrossRef
8.
go back to reference Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study Report 5. Arch Ophthalmol. 1990;108:958–64.CrossRef Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study Report 5. Arch Ophthalmol. 1990;108:958–64.CrossRef
9.
go back to reference Virata SR, Kylstra JA. Postoperative complications following vitrectomy for proliferative diabetic retinopathy with sew-on and noncontact wide-angle viewing lenses. Ophthalmic Surg Lasers. 2001;32:193–7.PubMed Virata SR, Kylstra JA. Postoperative complications following vitrectomy for proliferative diabetic retinopathy with sew-on and noncontact wide-angle viewing lenses. Ophthalmic Surg Lasers. 2001;32:193–7.PubMed
10.
go back to reference Gupta B, Sivaprasad S, Wong R, et al. Visual and anatomical outcomes following vitrectomy for complications of diabetic retinopathy: the DRIVE UK study. Eye (Lond). 2012;26:510–6.CrossRef Gupta B, Sivaprasad S, Wong R, et al. Visual and anatomical outcomes following vitrectomy for complications of diabetic retinopathy: the DRIVE UK study. Eye (Lond). 2012;26:510–6.CrossRef
11.
go back to reference Misra A, Ho-Yen G, Burton RL. 23-gauge sutureless vitrectomy and 20-gauge vitrectomy: a case series comparison. Eye (Lond). 2009;23:1187–91.CrossRef Misra A, Ho-Yen G, Burton RL. 23-gauge sutureless vitrectomy and 20-gauge vitrectomy: a case series comparison. Eye (Lond). 2009;23:1187–91.CrossRef
12.
go back to reference Nagpal M, Wartikar S, Nagpal K. Comparison of clinical outcomes and wound dynamics of sclerotomy ports of 20, 25, and 23 gauge vitrectomy. Retina. 2009;29:225–31.CrossRef Nagpal M, Wartikar S, Nagpal K. Comparison of clinical outcomes and wound dynamics of sclerotomy ports of 20, 25, and 23 gauge vitrectomy. Retina. 2009;29:225–31.CrossRef
13.
go back to reference Sivaprasad S, Hykin P, Prevost AT, Vasconcelos J, Riddell A, Ramu J, Murphy C, Kelly J, Edwards RT, Yeo ST, Bainbridge J, Hopkins D. Intravitreal aflibercept compared with panretinal photocoagulation for proliferative diabetic retinopathy: the CLARITY non-inferiority RCT. NIHR Journals Library: Southampton (UK); 2018 Oct. Sivaprasad S, Hykin P, Prevost AT, Vasconcelos J, Riddell A, Ramu J, Murphy C, Kelly J, Edwards RT, Yeo ST, Bainbridge J, Hopkins D. Intravitreal aflibercept compared with panretinal photocoagulation for proliferative diabetic retinopathy: the CLARITY non-inferiority RCT. NIHR Journals Library: Southampton (UK); 2018 Oct.
14.
go back to reference Alagöz C, Yıldırım Y, Kocamaz M, Baz Ö, Çiçek U, Çelik B. Halil İbrahim Demirkale, Ahmet Taylan Yazıcı, and Muhittin Taşkapılı. The efficacy of Intravitreal Bevacizumab in vitreous hemorrhage of diabetic subjects. Turk J Ophthalmol. 2016;46:221–5.CrossRef Alagöz C, Yıldırım Y, Kocamaz M, Baz Ö, Çiçek U, Çelik B. Halil İbrahim Demirkale, Ahmet Taylan Yazıcı, and Muhittin Taşkapılı. The efficacy of Intravitreal Bevacizumab in vitreous hemorrhage of diabetic subjects. Turk J Ophthalmol. 2016;46:221–5.CrossRef
15.
go back to reference Huang YH, Yeh PT, Chen MS, et al. Intravitreal bevacizumab and panretinal photocoagulation for proliferative diabetic retinopathy associated with vitreous hemorrhage. Retina. 2009;29:1134–40.CrossRef Huang YH, Yeh PT, Chen MS, et al. Intravitreal bevacizumab and panretinal photocoagulation for proliferative diabetic retinopathy associated with vitreous hemorrhage. Retina. 2009;29:1134–40.CrossRef
16.
go back to reference Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006;26:275–8.CrossRef Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006;26:275–8.CrossRef
17.
go back to reference Chelala EL, Nehme J, Rami H, Aoun R, Dirani A, Fadlallah A, Jalkh A. Efficacy of Intravitreal Ranibizumab injections in the treatment of vitreous hemorrhage related to proliferative diabetic retinopathy. J Retinal Vitreous Dis. 2018;38:1127–33. Chelala EL, Nehme J, Rami H, Aoun R, Dirani A, Fadlallah A, Jalkh A. Efficacy of Intravitreal Ranibizumab injections in the treatment of vitreous hemorrhage related to proliferative diabetic retinopathy. J Retinal Vitreous Dis. 2018;38:1127–33.
18.
go back to reference Randomized Clinical Trial Evaluating Intravitreal Ranibizumab or Saline for Vitreous Hemorrhage from Proliferative Diabetic Retinopathy, Bhavsar AR, Torres K, Beck RW, Bressler NM, Ferris FL III, Friedman SM, Glassman AR, Maturi RK, Melia M, Singer MA, Stockdale CR. Diabetic Retinopathy Clinical Research Network. JAMA Ophthalmol. 2013;131:283–93.CrossRef Randomized Clinical Trial Evaluating Intravitreal Ranibizumab or Saline for Vitreous Hemorrhage from Proliferative Diabetic Retinopathy, Bhavsar AR, Torres K, Beck RW, Bressler NM, Ferris FL III, Friedman SM, Glassman AR, Maturi RK, Melia M, Singer MA, Stockdale CR. Diabetic Retinopathy Clinical Research Network. JAMA Ophthalmol. 2013;131:283–93.CrossRef
19.
go back to reference Fassbender JM, Ozkok A, Canter H, Schaal S. A comparison of early and delayed vitrectomy for management of vitreous hemorrhage due to proliferative diabetic retinopathy. Investigative Ophthalmology & Visual Science an ARVO Journal. 2015;56:5117–42. Fassbender JM, Ozkok A, Canter H, Schaal S. A comparison of early and delayed vitrectomy for management of vitreous hemorrhage due to proliferative diabetic retinopathy. Investigative Ophthalmology & Visual Science an ARVO Journal. 2015;56:5117–42.
Metadata
Title
Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial
Authors
Ahmed Hosni Abd Elhamid
Ahmed Abd El Alim Mohamed
Abeer Mohamed Khattab
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Ophthalmology / Issue 1/2020
Electronic ISSN: 1471-2415
DOI
https://doi.org/10.1186/s12886-020-01401-4

Other articles of this Issue 1/2020

BMC Ophthalmology 1/2020 Go to the issue